GLOSSARY
A
ABC : Adverse Breast Cancer
Adjuvant : A treatment whose objective it is to prevent or stop the spread of cancer to other parts of the body. Often used after surgical removal of the primary lesion. These can include chemotherapy, immunotherapy, radiation, and vaccine therapy.
Adjuvant therapy : Adjuvant therapy is often used after primary treatments, such as surgery, to lessen the chance of the cancer coming back. Even if the surgery was successful at removing all visible cancer, microscopic bits of cancer sometimes remain and are undetectable with current methods.
Advanced tumor : Tumor that is unlikely to be cured or controlled with treatment.
Adverse Device Effect : Adverse event related to the use of a medical device. A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery.
Alpha-blockers : These drugs help lower blood pressure but also may be used to ease symptoms of an enlarged prostate.
Amniocentesis : A procedure used during pregnancy to take out a small sample of the amniotic fluid for testing.
Amniotic fluid : Liquid that surrounds the baby during pregnancy.
Ancillary study : Study that uses samples or data from a previous study to extend knowledge beyond the original scope of the previous study.
Antibody : An antibody is a molecule pertaining to the immune system that can specifically recognize a particular receptor expressed on the surface of tumour cell and bind to it
B
BRAF inhibitor : A treatment/drug that blocks a protein called BRAF
BRAF of NRAS mutation :
BRAF and NRAS are genes in the body that help control how the cells grow and divide. Sometimes, these genes can have alterations or mutations, which can cause the cells to grow out of control. This uncontrolled growth can lead to cancer.
BRAF V600 E/K : All humans have a gene called BRAF which is responsible for sending signals to proteins called B-Raf inside of cells that help them grow. In some melanoma patients, this gene mutates and causes cancer cells to grow in uncontrolled ways.
BRAF/MEK inhibitors : BRAF and MEK are genes that makes proteins which help control cell growth. In some patients with cancer, BRAF gene mutates and makes the tumor grow faster. Inhibitors are drugs designed to target these proteins (targeted therapy).
BRAFV600E : All humans have a gene called BRAF. The BRAF gene makes a protein that helps control cell growth. In some patients withcolorectal cancer, this gene mutates (V600E mutation) and makes the tumor grow faster.
C
Comparator group : Trial participants who have not received the treatment and will serve as a reference.
Coordinator : The study coordinator is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the study coordinator supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the study coordinator works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
Crossover trials : Crossover trials are trials in which participants do not only receive one intervention, but multiple, and the effect of the interventions are measured on the same individuals
D
Disease progression : Cancer that continues to grow or spread.
DMFS : The length of time from the start of treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body. In a clinical trial, measuring the DMFS is one way to see how well a new treatment works.
Duration of response : The time period the tumor continues to respond to treatment
E
Early Access Program : Program that gives access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. EAP offer ethical, compliant and controlled mechanisms.
Epstein-Barr virus : This is a very common herpes virus that infects most people worldwide and is usually spread through saliva. For most people, EBV infection does not cause serious health problems. After an initial infection, which can lead to symptoms such as fever and sore throat, the virus usually goes dormant and remains in the body without causing any problems. However, a weakened immune system (such as after transplantation) can allow the virus to become active again, potentially leading to complications and serious malignancies.
Extended adjuvant therapy : Adjuvant therapy provided following another adjuvant.
F
First line treatment : Initial, preferred or best treatment for a disease.
G
Genetic diagnosis of XLHED : DNA testing to identify the changes (mutation) on the EDA gene.
Good Clinical practice (GCP) : GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.
H
Healthy volunteers : Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and accept risks and constraints without anticipated health benefits from participation.
Hematopoietic cell transplantation : This is a medical procedure that involves the transplantation of blood stem cells. These stem cells are responsible for producing all the different types of blood cells in the body, including red blood cells (which carry oxygen), white blood cells (which fight infection), and platelets (which help the blood to clot).
HER2+ breast cancer : Breast cancer that expresses a protein called human epidermal growth factor receptor 2 (HER2)
I
Immunotherapy : Treatment that improves ability of the immune system to fight disease.
Informed Consent Form : A document in which patients are given important information in easy-to-understand language, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue.
Ipsum : Ici c'est la définition du terme
J
No terms starting with letter J
K
No terms starting with letter K
L
Lay protocol synopsis : Summary of the protocol which is written in non-technical easy to understand language.
Locally advanced : A locally advanced cancer is a cancer that has grown to a specific size, may consist of multiple tumors, and/or may have spread to adjacent lymph nodes, organs or tissue but has not yet spread to others part of the body
Longitudinal study : A longitudinal study is a study that involves patients' monitoring over an extended period of time.
LPI : Last Patient In
M
MEK inhibitor : A treatment/drug that block proteins called MEK and MEK, which help control cell growth and survival
Melanoma : Melanoma is a type of skin cancer that occurs when pigment-producing cells—known as melanocytes—mutate and become cancerous. Staging is defined by the characteristics of the original (primary) melanoma tumor and if/how far it has spread in your body. Melanoma is divided into stages using five Roman numerals (0 through IV) and up to four letters (A through D) that indicate a higher risk within each stage.
Metastatic : Metastasic means that cancer has spread to a different part of the body than where it started
Metastatic colorectal cancer : Metastatic colorectal cancer is a cancer that initially develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus) and has spread to other place(s) of the body
Metastatic melanoma : Once skin cancer spreads beyond the lymph nodes nearest the primary tumor, it has ravelled to a ‘distant site.’ A distant site may be an internal organ, skin not near the primary tumor, or lymph nodes other than those closest to the primary tumor.
Metastatic tumor : Metastasic means that cancer has spread to a different part of the body than where it started.
Mutation : A permanent change that occurs in a gene.
N
Neo-adjuvant therapy : Adjuvant therapy provided before primary treatment.
Non-small cell lung cancer : A groupe of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope
O
Open-label : A type of trial in which both the doctors and the participants are aware of the treatment being given.
Overall response rate : The proportion of participants ofr whom the tumors shrink or completely disappear after treatment
P
Pharmacokinetic : The pharmacokinetic of a drug is how the body absorbs, transforms, and eliminates this drug.
Pharmacovigilance : Science and activities relating to the detection, assessment, understanding and prevention of side effects or any other medicine-related problem
Phase I trials : Phase I trials test an experimental drug, vaccine or device in a small group of people to evaluate safety, identify side effects and determine safe dosages.
Phase I/Ib trials :
A Phase I/Ib trial is the first step in testing a new drug or treatment in humans. The main goals are to find the safest dose to give, to see how the body reacts to it, and to check for any side effects. This phase usually involves a small number of people, and if things go well, the treatment can move on to the next phase of testing.
Phase II trials : Phase II trials involve larger groups of people than Phase I and they are designed to assess whether an experimental treatment is safe and whether it works. This phase can last several years.
Phase III trials : This phase expands the drug or treatment testing to hundreds, sometimes thousands, of people. Some patients receive the new, or experimental, treatment alone or in combination with the standard of care. The goal is to provide data on efficacy, safety and side effects. The information from Phase III studies is often required to gain regulatory approval from groups like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Phytotherapy : Phytotherapy is the use of plant-derived medications in the treatment and prevention of disease.
Pivotal clinical study : Clinical study intended to demonstrate and confirm the safety and efficacy of a treatment.
Placebo : A placebo is an inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested.
Plain/lay language summary of results (PLSR) : Summaries that share the results of clinical and observational research in easy-to-understand words and graphics. For each summary, we also include feedback from a panel that includes at least patient, a lay expert, and member of the general public to make sure the summary is understandable.
Post-authorisation safety study : Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.
Post-Transplant Lymphoproliferative Disease : This is a condition that can occur in people who have received solid organ transplant or cell transplant. Due to the weakened immune system the Epstein-Barr Virus may not be controlled effectively, and the infected cells can grow uncontrolled, leading to this malignancy. The symptoms can vary widely, from just feeling generally unwell to more serious signs like fevers, night sweats, and weight loss.
Prenatal trial : A clinical study to test a treatment given to unborn babies while they are in their mother’s womb.
Primary completion date (intermediate analysis) : The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
Primary objective : In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Progression-free survival (PFS) : The time period between the treatment start and the disease worsens.
Prospective enrollment : Enrollment in the study conducted at or before treatment initiation.
Prospective study : Study where researchers will follow and observe a group of subjects over a period of time to gather information and record the development of outcomes
Protocol : A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what information will be collected.
Q
No terms starting with letter Q
R
Randomization : Randomization In research, the process by which participants in clinical trials are assigned by chance to separate groups that are given different treatments or other interventions. Neither the researcher nor the participant chooses which treatment or intervention the participant will receive. Using chance to assign people to groups means that the effects of the treatment or intervention that participants receive can be compared more fairly
Retrospective : Study in which participants with known outcomes are assessed based on data collected before the study.
Retrospective enrollment : Enrollment in the study conducted after treatment initiation.
RFS : In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the RFS is one way to see how well a new treatment works. Also called DFS, disease-free survival, and relapse-free survival.
S
Second line treatment : Effective treatment administrated when the first line treatment may not work, may start but then stop working or may cause serious side effects.
Side effects : Side effects are unwanted medical events (such as headache) that happen during the trial and that are related or possibly related to trial treatment.
Solid organ transplant : This is a surgical procedure where a failing or damaged organ in a person's body is replaced with a healthy organ from a donor.
Solid tumor : A type of tumor that is an abnormal mass of tissue that usually does not contain liquid areas
Survie sans maladie à distance : Temps écoulé entre le début du traitement et le moment où le participant est encore en vie et ne présente pas de métastases. Dans le cadre d’un essai clinique, la mesure de la survie sans maladie à distance peut aider à déterminer l’efficacité d’un nouveau traitement.
T
No terms starting with letter T
U
Unresectable : That cannot be removed by surgery
V
No terms starting with letter V
W
No terms starting with letter W
X
XLHED : Rare genetic disease characterized by a reduced ability to sweat, missing teeth, and fine sparse hair. The disease is caused by specific changes (mutations) in a gene called EDA which makes a protein called EDA1 (Ectodysplasin-A1). If EDA1 protein is absent or not working correctly during the baby’s development, important structures like sweat glands, hair, teeth do not form properly.
Y
No terms starting with letter Y
Z
No terms starting with letter Z