Clinical trials are essential for advancing and improving cancer management and, consequently, patient care.
What is a clinical trial?
Clinical trials are designed toevaluate new cancertreatments or care modalities. Indeed, before offering new treatments to all patients concerned, it is imperative to prove that these new treatments are effective and well tolerated.
Among clinical trials, "therapeutic trials" make it possible to evaluate, in particular:
- new drugs or combinations of drugs (to treat the disease or its side effects), compared in some cases with existing treatments;
- new ways of administering them (tablets rather than injections, for example);
- new treatment techniques (new types of surgery or radiotherapy, for example).
Other clinical trials may involve new diagnostic techniques (a new biological test, for example) or prevention techniques.
Why take part?
Patient participation in clinical trials is a vital contribution to the discovery of new treatments and strategies that can benefit a large number of people affected by cancer.
Progress in medicine, particularly in cancer treatment, is the fruit of clinical research, thanks to trials conducted with rigor and method, guaranteeing a high level of scientific proof.
However, there are still many situations that demonstrate the uncertainty and inadequacy of current therapies. Much progress remains to be made, both in the search for new treatments and in the development of new therapeutic strategies.
Clinical trials in progress
You can consult the trials currently open for inclusion at the Centre François Baclesse on the Archimaid site of the OncoNormandie network:
Early-phase clinical trials
Early-phase clinical trials represent the initial phases of drug development, prior to marketing. This gives patients access to innovative and promising drugs that do not yet have marketing authorization. Offering to take part in an early-phase clinical trial means offering an alternative to patients who no longer respond to conventional treatments, or who suffer from a rare form of cancer.
At the Centre François Baclesse, the main early-phase trials offered to patients concern :
- Trials of new drugs with different mechanisms of action, including immunotherapy, targeted therapies, epigenetic drugs, nanoparticles, etc.
- Trials of new drugs in combination with each other or with radiotherapy
- Precision medicine trials in which a drug is based on an identified molecular alteration. These drugs may be targeted therapies or immunotherapies.
Since 2010, INCa has contributed to the deployment of early-phase trials in France (logistical and financial support) through the creation of 16 INCa-labeled early-phase centers (CLIP²).
Since 2010, and for the third time in a row, our Center has been awarded the CLIP2 label in 2019, "Labeled Center for Early Phases in Adult Oncology".
Specificity of care
Early-phase trials are conducted in a specialized unit, with dedicated nursing staff and inpatient beds.
In these trials, patients are closely and rigorously monitored. The aim is to guarantee their safety and to understand how their body and tumor react to this new therapeutic strategy.
Experimental drugs for patients enrolled in clinical trials
Health data - Scientific research
As part of its care, research and teaching missions, the Centre François Baclesse is involved in scientific research into cancer, with the aim of improving prevention, screening and care.
Some of the data collected and generated during your treatment or follow-up may be used to conduct cancer research with health objectives, epidemiological studies, description of therapeutic strategies, medico-economic evaluations, to improve access to therapies and for teaching purposes.
This data will be used confidentially and in compliance with the regulations in force, in particular Regulation (EU) No. 2016/679 on the protection of personal data (RGPD) and Law No. 78-17 of January 6, 1978 known as the " Loi informatique et Libertés " as amended, in the public interest in the healthcare field.
You have the following statutory rights with regard to the data concerning you:
- data access rights,
- the right to rectify inaccurate data,
- right to erasure of data in the event of unlawful processing,
- right of portability allowing you to obtain the data you have supplied to the establishment,
- the right to limit data processing, particularly if this is challenged.
You also have the right at any time to object to the re-use of data contained in your medical file under the conditions defined by the RGPD.
Your data will only be used if you have not objected in the past. If you wish to object, have any queries or are dissatisfied with these rights, please contact the school's data protection officer: dpo@cfb.unicancer.fr
In accordance with current regulations, all research initiated by the Center, covered by CNIL Reference Methodology MR004 or a CEREES-CNIL authorization, and for which you have not been systematically informed directly by hand delivery or by sending an information note, is recorded on the Unicancer "My Health Data" reference site:
Patient information workshop
As part of the "ERI Meetings for Patients" program, the Clinical Research team regularly hosts a group workshop entitled: Participating in a Therapeutic Trial. This workshop lasts 1.5 hours and is organized via videoconference during the health crisis.
ERI meeting: "Participating in a therapeutic trial
" Registration and information about the next session atthe Meeting and Information Center (ERI) at the François Baclesse Center: +33 (0)2 31 45 50 64 / eri@baclesse.unicancer.fr