Here you will find an alphabetical overview of the technical terms relating to clinical research in general.
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Additional treatment after full surgical removal of a tumor in order to prevent a recurrence.
Unwanted accompanying events that occur when a treatment is administered in the correct way.
From other people; e.g. allogenic bone marrow transplant.
Partial or total hair loss; possible side-effect after chemotherapy or radiation of the head region.
Just short stay in hospital without admission, as opposed to hospitalized.
Painkiller a drug inducing relief of pain without loss of consciousness.
Drug to prevent the urge to vomit; often used to prevent vomiting in patient having chemotherapy.
A protein present in blood that fights diseases by recognizing foreign substances present for example on bacteria.
Substance that triggers the formation of antibodies.
Cell death that is controlled and actively triggered (programmed) by cells. The inhibition of apoptosis genes can lead to uncontrolled cell division and probably plays a role in the development of cancer.
Not harmful. Benign tumors respect the natural tissue boundaries, unlike malignant tumors. They can become very large, but do not penetrate neighboring tissue and do not produce metastases.
A biopsy is a tissue sample taken from the body in order to examine it more closely.
Procedure used to ensure that mental influences and expectations do not distort the outcome of a study. In a blinded study (single- or double-blind study), the study participants do not know which study group they are in, i.e. whether they are receiving a new treatment or a placebo.
Cancer located in the breasts.
Umbrella term to describe all malignant tumors or neoplasms including metastases. Benign tumors or cell clumps should not be referred to as cancer.
Substance that causes or promotes cancer.
Malignant tumor that spreads from epithelial tissue, i.e. skin, mucous membrane or glandular tissue. Carcinomas are further differentiated according to the appearance and origin of the cells.
Carcinoma in situ
A tumor that is malignant in nature in terms of its cell composition but that is limited to a particular location, is not fast-growing, does not cross natural tissue boundaries and is not connected to the vascular system. It is a precursor stage of cancer.
A chemical substance that inhibits growth of tumor cells (cancer cells) in the body by interfering with cell division (cytostatics).
Carriers of the genetic material in the cell nucleus; they contain the DNA chain molecule. Normal human body cells have 46 chromosomes, but the number and/or structure of chromosomes often varies in cancer cells.
Scientific investigations of people for people conducted according to strict medical and ethical rules. Their purpose is to obtain information in order to formulate better and more effective treatment recommendations.
Therapy involving more than one drug or treatment method.
The patient’s willingness to cooperate with diagnostic and therapeutic measures or to follow prescribed treatment.
Risk factor that distorts the results of a study or conceals the actual cause.
Second treatment after induction therapy for leukaemia with the aim of destroying remaining cancer cells by means of chemotherapy or radiotherapy.
Condition or situation which means that a particular treatment is not advisable.
Includes the study participants who are not receiving the new treatment but who, depending on the type of study, are receiving the standard treatment or standard procedure or a placebo.
Treatment with the intention of curing the condition, in contrast to palliative therapy.
Unit (of a treatment) that is repeated several times according to a schedule.
Microscopic examination of cells from smears, blood or tissue samples (biopsies) to detect pathological changes.
Non-endogenous substances that prevent the reproduction of tumour cells and often harm healthy cells in the process. Cytostatic drugs include both synthetic drugs and plant extracts.
Differentiation of tumour cells describes their similarity to or difference from normal cells of the organ in which the tumour has formed. Highly differentiated tumour cells are very similar to normal cells, while undifferentiated tumour cells are very different.
Desoxyribonucleic acid. Carrier of the genetic information of a living organism in the chromosomes in the cell nucleus.
A study in which neither the patient nor the study doctor know which patient is receiving which active substance (or placebo).
Malformation, deviation of the tissue structure from the normal situation. Dysplasias can be precursors of cancer.
Related to the hormone system.
Measurement point in a study to determine, for example, the occurrence of a disease, a symptom or a lab value.
A record of the frequency of new conditions (incidence), deaths (mortality), causes and risk factors.
Red blood cells.
High-level independent inspection bodies that assess the ethical and legal consequences of a study and ensure that study participants are protected.
The first therapy that will be tried (sometimes called induction therapy, primary therapy, or front-line therapy).
Emerging from a focus of disease.
Hereditary factor, section of a molecule chain consisting of desoxyribonucleic acid (DNA). Genes are responsible for certain hereditary structures or functions of an organism.
The insertion of genes into body cells to replace missing/altered genes in order to treat disease.
Good Clinical Practice
International guideline for the proper conduct of a clinical study.
The classification of tumours and tumour tissue according to their degree of differentiation. The figure (usually G1 to G3) describes how much the cancer cells differ from healthy, mature (differentiated) cells. This information is used to determine the malignancy of the tumour.
Relating to blood or blood formation.
The science of the fine structure of body tissue
Chemical messenger substances formed in the body that reach their sites of action through the bloodstream. Hormones regulate growth, metabolism and reproduction, and can promote or reduce the growth of cancer cells.
Excessive, benign cell reproduction of tissue.
The body’s defence system, protecting it against pathogens. It eliminates micro-organisms like viruses, bacteria and fungi, and plays a part in combating endogenous or other pathogenic cells that have become defective.
Form of treatment in which cells or messenger substances of the endogenous defence system are used to bring about a defence reaction against tumour tissue.
Frequency of new conditions, usually expressed per 100,000 residents per year.
The first step in cancer treatment, using chemotherapy or radiotherapy to try to reduce the size of the tumour, or the cell count in the case of leukaemia.
Invasive; in the case of tumours: spreading to surrounding tissue and destroying it.
The voluntary consent (usually in writing) or study participants after they have been informed about the purpose, conduct, expected benefits and risks and their rights and responsibilities
First treatment after diagnosis of an advanced tumour condition.
Involving a number of different areas of specialisation.
Large study conducted by several research groups on several thousand patients.
An impairment, change or injury to an organ or limb.
Blood cancer; umbrella term for a type of cancer that occurs in the tissue that forms the blood (bone marrow). This is initially broken down into acute (rapidly progressing) and chronic (slowly progressing) forms of leukaemia. The division into myeloid or lymphatic leukaemias refers to the type of precursor cells that have become degenerate.
White blood cells.
In a specific area.
Cancer of the lymphatic system (lymph gland cancer). There are many types of lymphoma, which can be divided into two groups: Hodgkin’s lymphoma (HL) (usually restricted to the lymph glands) and non-Hodgkin’s lymphoma (NHL) (can occur almost anywhere in the body).
Harmful. In contrast to benign tumours, malignant tumours do not respect natural tissue boundaries but penetrate and destroy other tissue and can produce metastases in parts of the body far from their origin.
Secondary tumours. These occur when cancer cells from the primary tumour are transported to other parts of the body via the bloodstream or lymphatic system. Metastases allow malignant tumours to be formed in other parts of the body.
Proteins (immunoglobulins) that react with a single antigen. Researchers develop monoclonal antibodies that bond to specific antigens on the surface of the cancer cells in order to trigger an immune defence against these cells or to introduce a cancer-killing substance.
Treatment with a single drug.
Likelihood of an individual developing a particular disease or condition.
Proportion of deaths, normally expressed per 100,000 residents.
Carried out at several hospitals (centres) at the same time.
Change in the sequence of building blocks in the DNA genetic molecule. Mutations can lead to changes or losses in the function of genes, and so affect the behaviour of cells.
Pre-operative treatment (e.g. chemotherapy) carried out before surgery to remove a tumour. It is designed to reduce the size of the tumour and/or kill off tiny tumour cell clusters.
Newly-formed abnormal cell growth, new formation, formation of new tissue, often malignant.
Genes that are involved in the development of cancer. They are only carcinogenic if they have certain defects. Intact oncogenes have important regulatory functions in the cycle of cell division.
The study of the development, diagnosis and treatment of cancers. In the modern understanding, this also involves the care, after-care, psychological support and rehabilitation of patients.
Both the doctor and the patient know the study group to which the participant belongs.
Via the mouth.
The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.
An expression of statistical significance. A p-value of less than 0.05 means that the likelihood of the result being due to chance is less than 5%.
Treatment given to relieve the symptoms and reduce the suffering caused by cancer and other life-threatening diseases.
Treatment aimed at relieving symptoms or preventing complications in the case of incurable cancers, in contrast to curative therapy.
Causing disease, or a substance that does so.
Related to disease.
Doctor who investigates and assesses pathological changes to body tissues and cells.
Informs patients about the purpose, intention, effects and side effects of investigations and treatments. Written patient information is always provided to complement the information given by the doctor if the treatment is planned in the context of studies.
Through the skin.
Positron Emission Tomography. Computerised imaging procedure that produces images of cross-sections of bodily organs from which metabolic processes can be seen.
The study of the effects of drugs in the body, especially the profile of action, mechanism of action and the dose-effect relationship.
Description of the mechanism of action, i.e. the release, take-up, distribution, metabolisation and secretion of a particular drug.
Phase I study
First study in man; the search for new treatment methods that until this point have only been tested in the laboratory and in animal experiments.
Phase II study
Phase II studies investigate how effective and safe the new treatment is at the specified dose in combating a particular type of cancer.
Phase III study
The new treatment is compared to the usual method in order to find out whether the new treatment method is better.
Phase IV study
Rare side effects and interactions with other drugs are ascertained after the drug has been authorized for use.
A dummy drug that does not contain any active substance.
Effects and side effects caused by a dummy drug for which there is no pharmacological explanation. The placebo effect is based on positive expectations and mental effects.
Tests carried out in the laboratory and on animals to thoroughly investigate a newly developed drug before the clinical phase and before use in humans.
Frequency of a particular condition at a particular time in a defined group, usually the entire population
The tumor which developed first; of which metastases originate.
The advance of the disease.
Reproduction of cells or tissue.
Surgical removal of tumor, in which the entire organ and if necessary large sections of surrounding tissue are removed in order to ensure that tiny tumor cell clusters nearby are also captured.
Combination of chemotherapy and radiotherapy (at the same time or consecutively).
The use of short-wave, very high-energy radiation, alone or in combination with other measures, to combat malignant tumours.
A procedure followed in clinical studies, whereby participants are allocated at random to one or more treatment groups. The aim is to prevent the proven effect being subject to systematic bias.
Recurrence, reappearance of a disease.
Decline of the disease. Complete or partial regression of the tumour, normally in response to treatment.
Insensitivity to a treatment, e.g. of tumour cells to chemotherapy or of bacteria to antibiotics.
Type of cancer starting in the bones, cartilage, fatty tissue, muscles or blood vessels.
Early detection of diseases before they become apparent through symptoms.
Therapy that is applied when, after completion of the first treatment (first-line therapy), a therapeutic success fails, e.g. a tumour grows again or metastases form.
Importance; the difference between two treatments is significant if it is large enough that the study outcome cannot be due to chance.
A person, company, institution or organisation that is responsible for initiating, organising and/or funding the study.
The process of recording and classifying the local extent of the tumour, lymph node status and remote metastases (TNM classification) in order to find the most suitable treatment
The conventional treatment whose efficacy has already been tried and proven. The best treatment available at the time.
Patients are allocated to a study arm for a treatment that is to be investigated by comparison with another treatment. A study can include various study arms, e.g. an arm with a new treatment and an arm with standard treatment.
A healthy study participant.
Prevention and treatment of complications and side effects of cancer therapy.
Not responding to a treatment/not treatable by the standard therapy.
Therapy that is used when the effect of a second-line therapy diminishes or its therapeutic success fails, e.g. a relapse occurs or metastases form.
The poisonous effect of a substance, e.g. a cytostatic.
The doctor leading and conducting a clinical study. He/she is highly qualified and already has experience with clinical studies.
Swelling; in the strictest sense, a growth caused by the proliferation of cells that have escaped normal growth control; benign or malignant.
Endogenous substances that enter the blood in higher concentrations when cancer is present. They are used mainly to monitor the course of known cancers: a rise in tumour marker concentration in the blood can be a sign of tumour growth. Markers can also be detected in other bodily fluids and tissue.