BCB RIV: Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Recruiting

CT.gov ID

NCT04104529

Collaborator

(none)

350

Enrollment

Location

Arm

59.1

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Development of a prospective clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Prostate Cancer Neuroendocrine Tumors	Other: Biological collection	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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 :

Oct 28, 2019

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biological collection 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.

Arm

Intervention/Treatment

Experimental: Biological collection

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients who gave their consent to participate in the study [Until the study completion: 5 years]
The proportion of patients who consent to participate in the study among the screened patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ at 18 years old,
Patient treated in the ICM Nuclear Medicine Department for the treatment by metabolic radiotherapy,
Patient treated at ICM as part of his treatment for:
thyroid cancer,
a neuroendocrine tumor or
prostate cancer.
Patient having accepted the complementary blood sample,
Patient having given his informed, written and express consent.

Exclusion Criteria:

Patient not affiliated to a social security scheme,
Subject under tutelage, curatorship or safeguard of justice,
Patient in an emergency situation
Patient whose regular monitoring is a priori impossible for psychological, family, social or geographical reasons,
Pregnant and / or breastfeeding woman