Observational studies: some examples in hematology.

Among the clinical trials, we find interventional trials and observational trials.

Les observational tests(or non-interventional) correspond to all studies that do not do not require additional actions compared to routine treatment of the patient but whose objective is to collect data (prospectively or retrospectively) and analyze them to improve scientific knowledge.

The objectives of observational trials are multiple and aim in particular to better understand the diseases studied, optimize diagnosis, analyze the effects of treatment in real life or even evaluate screening and prevention tools.

In some cases, for the collection of health data, are set up registries, generally targeting a particular pathology. Data can be collected in the form of questionnaires, biological samples (blood, cells, saliva, etc.) or even imaging exams.

As with an interventional trial, the patient must sign, before being included in the registry, a written consent of participation after receiving all the information related to the study.

As an example, here are two registers proposed by LYSARC:

The LYSATOMIC register

LYSATOMIC is a non-interventional clinical study, targeting T-lymphomas, opened in France and Belgium. The aim of the test is twofold. On the one hand, identify molecular markers making it possible to predict the response to a treatment implemented as part of a T-cell lymphoma and on the other hand, discover new therapeutic targets innovative. For this, biological sample collections, which may include blood, saliva, tissue, hair bulbs..., are performed at regular intervals during treatment or during new events (relapse, transplant,...). These samples will then be analyzed in order to understand the molecular heterogeneity of T lymphomas.

The LAGC-AIM register

An observational study of LAGC-AIM (Anaplastic Large Cell Lymphomas Associated with Breast Implants) was implemented by LYSARC in France. The aim is to establish the most complete database possible of cases of this type of lymphoma, affecting women with breast implants. The data collected includes, among other things, the treatments received for potential breast cancer, the type of prosthesis used, the clinical characteristics of lymphoma as well as the evolution of the disease. In addition, certain data, including imaging and ultrasound exams, will be made available, via a secure web platform, CPRs (Multidisciplinary Concertation Meeting) organized to study the files of patients affected by an ALGC-AIM.

For more information on these registers, you can consult the site of the LYSARC.

Sources: CHUV, Lysarc, Saint-Luc University Clinic