Frequently Asked Questions
It is the research that is carried out on people with the aim of developing knowledge that improves human health or increases the understanding of human biology. People who participate in clinical research make it possible for this to happen.
Clinical studies or trials are part of biomedical research. The objective of clinical trials is to determine if a new test or treatment works and is safe, the most important medical advances occur with this type of studies. El objetivo de los ensayos clínicos es determinar si una nueva prueba o tratamiento funciona y es seguro, los más importantes avances médicos se dan con este tipo de estudios.
To research new treatments or tests to prevent, detect, or treat diseases. Treatments can be drugs, surgical treatments, devices, vaccines, or new ways to use existing treatments.
There are international ethical guidelines that all countries conducting clinical research must apply. The purpose of these ethical guidelines is to protect people who participate in research and seek to preserve the integrity of science.
Additionally, each country has its own laws or regulations.
TAll clinical research in Costa Rica must comply with the Biomedical Research Regulatory Law No. 9234. In fact, Costa Rica is one of the few countries in Latin America where biomedical research is regulated by law and not by other forms of regulation such as decrees. As established by law, the CONIS (National Health Research Council, of the Ministry of Health) is the governing body in biomedical research at the national level and its purpose is to guarantee the quality of research and its strict adherence to the protection of the people who participate as volunteers in these investigations.
They are volunteers, they can be healthy or with some health condition, each study invites people to participate according to the objective of the research.
a) Natural history studies: Are used to understand how diseases progress over time, providing information on the best way to treat and/or prevent these diseases.
b) Prevention studies: Research ways to prevent a disease in people who have never had the disease or to keep the disease from progressing. They include research on drugs, vaccines or lifestyle changes, among others.
c) Screening studies: Evaluate tests or methods to find the best way to detect certain diseases or health conditions.
d) Diagnostic studies: evaluate tests or procedures to diagnose a disease.
e) Treatment studies: investigate new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
f) Quality of life studies: explore ways to improve the quality of life of people with a chronic disease.
Clinical studies to test a drug are done in “phases”. Each phase has a different purpose and helps researchers answer different questions.
Phase 1 is when the new drug or treatment is first tested in humans. Few people (20-80) participate in this phase. The purpose is to find a dose that is not dangerous and to know how it affects the body.
In phase 2 a little more people (100-300) participate, in this phase they search, determine the effectiveness of the medication or treatment, that is, evaluate if it serves what it was created for and continue evaluating if it is safe for people.
In phase 3, many more people (1,000-3,000 or more) participate with the purpose of confirming if the drug or treatment is effective, that is, if it serves to treat or prevent a disease or condition, the effects that the drug also continues to be evaluated has on the body (side effects) and the new treatment is compared with the one that currently exists to find out which is the best. If it is proven that the medicine or treatment is effective and safe, the regulatory entities will grant permits for its use and sale to the public.
In phase 4, even if a drug or treatment is already approved and sold to the public, its risks and benefits continue to be evaluated.
In Costa Rica, participation in biomedical research must always be voluntary, so participants are not paid. Only expenses eventually incurred by the subject for their participation in the research may be reimbursed. Solo podrán reintegrarse los gastos en que eventualmente incurra un sujeto por su participación en la investigación.
No, in Costa Rica only a researcher who practices a profession recognized by the State and accredited by the CONIS (National Council for Health Research, of the Ministry of Health) can carry out biomedical research.
Cáncer
Normally, human cells grow and divide to form new cells as needed by the body. When normal cells get old or damaged, they die and new cells replace them.
Cancer can occur when this orderly process gets out of control, meaning old or damaged cells survive when they should die, and new cells form when they are not needed. These cells divide without stopping and can form masses called tumors. Many cancers form solid tumors (they are masses or balls of tissue). Blood cancers, such as leukemias, generally do not form solid tumors.
Cancer can start almost anywhere in the human body. Tumors that are cancerous or malignant are those that can spread to or invade other tissues in the body. Benign tumors, although they can be large tumors, never invade other tissues, and when tumors are removed, they usually do not reform.
There are more than 100 types of cancer. Types of cancer are generally named after the organs or tissues where they form. For example, cervical cancer starts in the cells of the cervix, and anal cancer starts in the cells of the anus.
This will depend on various factors. Some factors that will determine the possibility of cure and the prognosis are the following:
a) The type of cancer and where it is located in the body.
b) The stage or stage of the disease (the size of the cancer and whether it has spread to other parts of the body).
c. El grado del cáncer (qué tan anormales se ven las células cancerosas al microscopio). El grado nos da una idea de la rapidez con que puede crecer y extenderse
d) Certain characteristics of cancer cells.
e) Age and health status before cancer.
f) The response to treatment.
Anyone can develop cancer; children, youth, adults, seniors; be men or women.
An assessment by a medical professional is important, who will determine what additional studies are needed to make a diagnosis.
No, cancer is not an infectious disease, people who have cancer do not pass it on to healthy people.
You can obtain information on this topic from your doctor. You could also find reliable information on some websites such as the US National Cancer Institute (NCI), the World Health Organization (WHO) and the US Centers for Disease Control and Prevention. (CDC), If you would like to have access to books that contain information related to this subject, you could go to the BINASSS (National Health and Social Security Library) located in the facilities of the San Juan de Dios Hospital. For more information you can visit the following sites:
HUMAN PAPILLOMAVIRUS
It is an infectious agent so small that it cannot be seen using a normal microscope, and in order to survive and multiply, it must enter the cells of other organisms. They infect any type of organism: humans, fungi, animals, plants, bacteria. Infectan cualquier tipo de organismo: seres humanos, hongos, animales, plantas, bacterias.
In order to survive and reproduce, viruses need to enter the cells of another organism (host), whereas bacteria can reproduce on their own.
They also differ in size. Bacteria are generally much larger than viruses and can be seen under a standard light microscope.
Viruses are transmitted in many different ways, and each type of virus has a different method of transmission. Some viruses use transmission vectors, for example, mosquitoes are the vector for the Dengue virus. Other viruses do not require vectors, for example, the influenza virus is spread through the air through sneezing and coughing, the AIDS virus (HIV) is transmitted by sexual contact or by exposure to infected blood.
Human papillomaviruses are a group of more than 200 related viruses. It was given this name because some types of HPV can cause warts or papilloma on the skin and genitals. Each HPV virus in this group is assigned a number that designates the HPV type, for example, HPV-1, HPV-2, HPV-3 etc.
HPV is transmitted through skin-to-skin or mucosa-to-mucosa contact (mucosa are moist parts such as the mouth and genitals). Some types of human papillomavirus infect the genitals (about 40 types of HPV) so they are transmitted through sexual contact, that is, it can be contracted by having vaginal, anal, or oral sex with someone who has the virus. HPV types that infect other parts of the body are transmitted through skin-to-skin contact.
In the vast majority of people, HPV infections (9 out of 10) go away on their own within two years and do not cause any health problems. But when HPV doesn’t go away, it can cause:
- In women cancer of the cervix, vagina and vulva.
- In men penile cancer.
- In men and women, cancer of the anus and cancer in the back of the throat. It can also cause genital warts.
Some of the HPV types that are not sexually transmitted can cause warts or non-genital warts.
Warts or petty ones that occur anywhere on the body will never become cancer.
Yes, men get HPV in the same way as women that is through sexual contact. HPV-associated cancers in men, such as anal cancer, penile cancer, or throat cancer, are rare. Los cánceres asociados al VPH en varones, como el cáncer de ano, el cáncer de pene o de la garganta son poco frecuentes.
Of the sexually transmitted infections, HPV infections are the most common. HPV infections are so common that in most countries almost all men and women, after becoming sexually active, will have at least one type of HPV at some point in their lives.
High-risk papillomaviruses are the types of HPV that are capable of causing cancer. Most high-risk HPV infections occur without symptoms, and go away on their own 1 to 2 years after they were acquired. However, although less common, some HPV infections can stay for many years. Persistent infections with high-risk HPV types can cause cell changes that can eventually lead to cancer. There are 12 types of HPV classified as high risk, these are HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. These 12 types of HPV cause cancer of the cervix, however, the most carcinogenic are HPV 16 and 18 because together they cause 70% (7 out of 10) of all cases of cervical cancer
100% of cases of cervical cancer are caused by one of the high-risk types of HPV.
The uterus is the organ where babies grow. The narrow part of the uterus, which is at the lower end, is the cervix. The cervix connects the uterus to the vagina, is about 3 centimeters long, and is thin and flexible.
No, uterine cancer can occur in different parts of the uterus. It can originate in the muscular layer of the uterus (myometrium) or in the tissue inside the uterus (endometrium) or in the cells of the cervix or cervix. When we talk about cervical cancer, we refer to cancer that originates in the cervix, which is the lower part of the uterus.
In women, one way to determine if you have HPV infection is by taking a sample of cells from the cervix and preparing the vaginal cytology or Pap smear. With this test, the cells of the cervix are observed under a microscope to see if they have changes in their morphology (shape) that indicate HPV infection. Another way is to take a sample of cells from the cervix or vaginal canal and send it to the laboratory for a laboratory test that determines the presence or absence of HPV.
Another way to know if a person (man or woman) is infected by the Papilloma Virus is through a physical examination carried out by qualified health personnel when observing the warts produced by HPV.
Vaginal cytology also called Papanicolaou is a screening test for the early detection of cervical cancer. Health personnel take the sample. The woman must lie on a gynecological table, then the doctor or nurse uses a speculum to separate the walls of the vagina so that they can see the bottom of the vagina. This allows the vagina and cervix to be examined and a sample of cells to be taken from the cervix. The cells are then placed on a slide or in a special liquid and sent to the laboratory for analysis.
In the laboratory, the slide is stained and specialized personnel observe the slide under a microscope to see if the cells have changes in their morphology that show HPV infection and if the infection could be causing precancerous lesions or cancer in the cervix.
The result of vaginal cytology is not a definitive result on the presence of precancerous lesions or cancer and it is necessary to do additional evaluations by the gynecologist
National recommendations should be followed and those of expert committees that periodically review how often screening tests should be done, also.
Currently, in Costa Rica, vaginal cytology screening is recommended every two years for all women between 21 and 65 years of age who have initiated sexual activity.
When a nurse or doctor observes the presence of warts on the genitals with the naked eye, this indicates that the person has the infection. However, genital warts will never turn into cancer.
To determine if a woman is infected with a high-risk virus and to know whether or not she has precancerous lesions or even cancer, it is not possible to determine it with the naked eye and it is necessary to take samples of cells from the cervix or an evaluation by a professional specialized.
A dysplasia or cervical lesion is the name given to the changes in the cells of the cervix produced by HPV. These changes in cells can only be seen under a microscope. Dysplasia do not hurt, are not seen and are not felt by the woman.
Dysplasia can be mild, moderate, or severe; this depends on what the cell looks like under a microscope.
No, dysplasia can only be diagnosed by looking at the cells of the cervix under a microscope and must be diagnosed by a specialist in this field.
For cervical cancer to develop, there must be an infection with one of the high-risk (carcinogenic) HPV types in the cervix. If the infection does not go away on its own and rather persists, over time HPV can alter the cells of the cervix and cause lesions, which, if left untreated, can slowly progress to cervical cancer. Screening programs seek to detect lesions in women in order to treat them before they turn into cancer.
The papilloma viruses that cause cancer are the high-risk ones. Most people with a high-risk HPV infection will never develop health problems. Most HPV infections (9 out of 10 infections) clear up on their own within two years, as our immune system (our body’s defenses) has the ability to eliminate it. If the body is unable to clear the infection and it persists for a long time, cancer may slowly develop. When infection with high-risk viruses persists, there is an increased risk of developing cervical cancer.
No, our body has the ability to eliminate these and other viruses, therefore, when we are infected with some viruses, including papilloma viruses, we can eliminate them and not live with them all of our life.
The condom provides some protection against HPV, but does not offer complete protection against infection. Condoms must be used correctly every time you have sex. Even so, condoms cannot provide complete protection because they do not cover all areas of the body that could transmit HPV, such as the skin of the genital or anal area. However, condoms provide protection against the vast majority of other sexually transmitted infections.
The immune system or defense system of our body is in charge of protecting us from infections and diseases. All people naturally have it to defend ourselves against infectious agents such as viruses, bacteria, fungi, it also eliminates cells from the body that can cause cancer. Todas las personas de forma natural lo tenemos para defendernos de agentes infecciosos como virus, bacterias, hongos, además elimina las células del cuerpo pueden producir cáncer.
The Immune System has two main functions: to recognize substances foreign to the body and to react against them. These substances can be microorganisms that cause infectious diseases, transplanted organs or tissues from another individual, or even tumors in our body.
The proper functioning of the Immune System provides protection against infectious diseases and can protect a person from cancer. It is also responsible when rejection of transplanted organs occurs.
One of the most important functions of the Immune System is protection against infectious diseases (Viruses, bacteria, fungi, parasites).
Whatever the agent, the immune system recognizes it as something foreign to our body and helps eliminate it.
In some people the defenses do not fulfill their function properly. There are immunosuppressed people in whom the immune system is weakened and makes them susceptible to infections by microorganisms that do not cause disease in healthy people, for example; people with HIV-AIDS, leukemia, organ transplants, drugs to treat cancer, etc.
In other people the immune system can produce an exaggerated immune response against substances and tissues that are normally present in the body, in this case the immune system attacks and destroys the body’s own organs and tissues for example in multiple sclerosis, rheumatoid arthritis, Lupus, etc.
When the cells of the cervix begin to change, it can take 10 to 15 years for invasive cancer to develop. The first changes in cells are dysplasia.
Let’s remember that there are three types of Dysplasia: mild, moderate and severe, if they are discovered early, they can be treated before the cells become cancerous.
Dysplasia, regardless of whether they are mild, moderate or severe, can heal on their own. Some moderate and severe dysplasia do not heal on their own, therefore, in most countries they are treated (which consists of removing the damaged tissue), mild dysplasias are not treated because it is proven that our defenses generally cure them. However, it is very important for each case to take into account some important aspects such as age and history of diseases, among other things. Each case will be studied separately.
Yes, let’s remember that there are many types of papilloma virus. People can be infected at different times with one or the other, as well as at some point we can be infected with several HPV at the same time.
Because your defense system acts and does not allow the virus or viruses to damage the cells until they produce cancer and eliminate it before that.
El virus del papiloma necesita tejidos especiales a los que infectar. Este tiene gran afinidad por tejidos con células en frecuente cambio y maduración como es el tejido que se encuentra en el cuello del útero, por lo que las mujeres al tener estos tejidos se ven mayormente expuestas al desarrollo de cáncer. En cambio, el tejido que recubre el pene en los hombres no presenta estas características.
HPV can also cause cancer in other parts of the body such as the anus, oropharynx, vagina, and vulva.
Warts are growths of skin that can appear on different parts of the body due to an HPV infection. There are warts on the skin, mouth, anus and genitals.
Genital warts or condylomas are produced by sexual contact. In these cases, HPV is transmitted by having oral, genital or anal sex with an infected person. Papilloma types 6 and 11 are the ones that cause most genital warts.
No, there are warts on the skin that are not associated with HPV, such as senile warts.
A doctor or specialist can diagnose a wart.
There are different types of treatment to remove warts such as:
- Topical medications.
- Freezing (Cryotherapy).
- Cauterization
- Laser.
However, since most warts are caused by an HPV infection, it is important to know that these treatments in general will only eliminate the wart but not the infection by the virus, so after the treatment it is possible that the wart appears again. We must know that our defenses are the only ones capable of eliminating the infection.
So far there are no drugs that can eliminate these viruses, if we get one or more papilloma viruses, our defenses are the only ones that can help us get rid of them.
There are vaccines that serve to prevent and protect us from some of these viruses, but these are not curative, only preventive.
VACCINES
Vaccines are products similar to medicines, but they make our body produce defenses that protect us from diseases caused by microorganisms such as viruses or bacteria and prevent us from getting sick. Vaccines can be injected or taken.
Vaccines protect us from diseases, what vaccines do is trick the body’s immune system, making it believe that it is being attacked by an infectious agent (if I am vaccinated against chickenpox; the body believes that chickenpox is attacking me) and forces it to defend himself. Thus, it is forced to create defenses, these defenses remain in the body and when we are really exposed to the infectious agent, we already have the defenses to eliminate it.
Through vaccines we can prevent the consequences of many infectious diseases, it is one of the public health measures that has saved most lives throughout history.
If people are not vaccinated, especially children, some diseases that have already been controlled and that appear very rarely worldwide (for example, polio, diphtheria, measles or rubella), could reappear in the form of outbreaks or epidemics. Diseases like these have been eliminated through vaccination and others continue to be controlled.
In the field of medicine, we can say that prevention is: taking measures in advance to avoid damage, risk or disease. Some diseases can be prevented; According to the World Health Organization, with the administration of vaccines, two to three million deaths of children are prevented each year in the world
There are different types of vaccines and they are made to prevent different diseases; they are made from viruses or bacteria that have been weakened, killed, or partially modified in such a way that they do not have the capacity to cause disease.
Vaccines have to meet the highest quality and safety standards.
The manufacture of a vaccine is a complex process, with several stages, rigorously controlled from start to finish.
It’s important to remember that vaccines undergo rigorous safety testing before they are approved by regulatory bodies such as the FDA, (the United States government agency responsible for regulating food and drugs) and that they are continuously monitored about their safety. The vaccine production process involves several phases of testing over many years, to ensure that they are safe to apply and that they are effective in preventing the corresponding disease. In each country the Ministry of Health is responsible for approving the use of vaccines. If a vaccine is sold in pharmacies, it is because it has such approval.
Not all vaccines are the same, each vaccine is made to prevent a specific infectious agent, although sometimes several vaccines are given together.
Also, it is important to know that vaccines too; they are made differently, have different components, can be applied in different ways, etc.
As with any medication, there are potential risks and side effects associated with vaccines. The risk of having an allergic reaction to a vaccine is small compared to the risk of serious complications from the disease they prevent. The benefits of vaccination are much more than the risks. The discomfort or unwanted effects that may appear after vaccination are usually mild with very rare exceptions. The risk of a serious side effect after receiving a vaccine is less than 1 in 1,000,000.
The most common reactions are usually pain, discomfort, swelling, or redness at the injection site. Fatigue, headache, itching at the injection site, nausea, dizziness, fever, rash, and fainting (more common in adolescents) may also occur less frequently. Serious side effects are rare, but can include life-threatening allergic reactions or seizures.
It is a list of vaccines with their respective periods of application that are recommended and must be received in a mandatory manner by the target populations that are defined by the National Commission of Epidemiology and Vaccination
The HPV vaccine is not recommended in pregnant women.
These vaccines are recommended for people who have not started sexual activity and who are close to starting it since it is a preventive vaccine that offers its maximum benefit before the infection is acquired after the start of sexual intercourse.
Yes, the studies that have been carried out so far confirm that these vaccines also protect against these types of cancer.
There are few data on the efficacy of the 3 HPV vaccines when used interchangeably. Since these vaccines have different characteristics and components, WHO recommends that efforts be made to apply the same vaccine, however, WHO notes that if this is not possible (for example, it is not known what the first dose was or could not obtained the same one) any of the other HPV vaccines can be applied to complete the scheme.
There are several groups of experts that are in charge of monitoring the reactions that are reported after the application of these vaccines, until now it has not been possible to determine that these reactions are related to the vaccine. HPV vaccines have been shown, after more than 180 million doses administered worldwide, to be very safe.
You can obtain information on this topic from your doctor. You can also find reliable information on some websites such as the World Health Organization (WHO), the US National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC). If you would like to have access to books and/or magazines that contain information related to this subject, you could go to the BINASSS (National Health and Social Security Library) located in the facilities of the San Juan de Dios Hospital. For more information you can visit the following sites:
http://www.who.int/immunization/diseases/hpv/es/
Currently they can be purchased in some private pharmacies in the country, which means that only people who can buy it have the possibility of applying it. At this time, health authorities approved the inclusion of these vaccines in the national vaccination scheme for all girls who are turning 10 years of age, therefore they are being administered in the Fund’s clinics or in schools to girls from this age.
Initially the vaccine was created to be applied in 3 doses; Thanks to some studies (including one carried out in Guanacaste), it was determined that applying 2 doses of the vaccine is just as effective as applying 3.
Recently, in 2022, the WHO Strategic Advisory Expert Group (SAGE) on immunization evaluated the evidence that has emerged in recent years that single-dose regimens provide comparable efficacy to two-dose regimens or three doses. Studies must continue.
Based on this, the WHO currently recommends that the HPV vaccine be applied as follows:
- A schedule of one or two doses for girls 9 to 14 years of age.
- A schedule of one or two doses for women aged 15 to 20 years.
Two doses 6 months apart for women 21 years of age and older, a first dose and a second dose 6 months after the first.
HPV infections are acquired very soon after the start of sexual activity. For this reason, it is recommended to get vaccinated before starting sexual activity, to obtain the maximum benefit from vaccination. After having started sexual activity, you can always apply the vaccine, but the benefit it offers decreases a lot after 4 years after having started sexual activity because the infection is acquired in the first years of having started sexual activity. However, this depends on several factors, such as the number of sexual partners and their sexual experience. The vaccine protects against types of HPV to which the person has not been exposed.
According to the years that this vaccine has been in use and the follow-up that has been given, studies regarding the duration of protection of the vaccine against human papillomavirus indicate that it protects for more than 10 years and so far, there is no evidence that need to apply reinforcement.
