Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department (BCB RIV)
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|ClinicalTrials.gov Identifier: NCT04104529|
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Prostate Cancer Neuroendocrine Tumors||Other: Biological collection||Not Applicable|
Targeted radionuclide therapy (TRT) aims at delivering ionizing radiation specifically to tumors for therapeutic purposes. Different types of radionuclides can be used to deliver the radiation: beta emitters less (Iodine-131, Lutecium-177), alpha (Radium-223) or Auger (Indium-111). They will target tumor cells either by natural tropism (iodine for thyroid cancer, for example) or by coupling them to a vector (antibody, peptide ...).
Patients with thyroid cancer, prostate cancer or neuroendocrine tumors who should benefit form TRT may be included in this project. The clinical-biological database will help better understanding of the radiobiological mechanisms of action of ionizing radiations on both normal tissues and tumor cells and the psycho-oncological mechanisms involved in patients treated with TRT. The collected data will help treatment optimization.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients. Integrated research associated with quality biological research is the guarantee of medical progress. The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Establishment of a Monocentric and Prospective Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department|
|Actual Study Start Date :||October 28, 2019|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||October 2024|
Experimental: Biological collection
For all the patients include in the study :
samples of blood samples collected before and during treatment.
In parallel to this biological collection, standardized clinical data will be entered into a database
Other: Biological collection
The biological collection will also include samples of blood samples collected before and during treatment.
- Proportion of patients who gave their consent to participate in the study [ Time Frame: Until the study completion: 5 years ]The proportion of patients who consent to participate in the study among the screened patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104529
|Contact: Jean-Pierre BLEUSE, MD||0467613102 ext +33||DRCIfirstname.lastname@example.org|
|Study Chair:||Emmanuel DESHAYES, MD||Institut régional du Cancer Montpellier|