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

Not Applicable

Recruiting

• Conditions: Thyroid Cancer; Prostate Cancer; Neuroendocrine Tumors
• Interventions: Other: Biological collection; Other: tumor collection

• Registration Number: NCT04104529
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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

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 (only for ICM's patients). 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).

An ancillary study "IMMUNORIV" is associated to BCB RIV : The specific research aim is, first, to determine whether immune cell (lymphocytes and macrophages) scoring and characterization in metastatic thyroid cancer and NET samples at diagnosis predict the response to TRT. Second, a high-throughput approach will be used to determine i) the immune cell profile in blood samples from patients with NET, before and after TRT initiation, and ii) its possible correlation with the response to TRT. Third, using imaging techniques the possible correlation will be evaluated between tumor uptake/absorbed dose and response to TRT.

By monitoring the immune response during TRT, the IMMUNORIV project will allow to identify immune response-related biomarkers that may be modulated to improve TRT effect.

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2019-10-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Age ≥ at 18 years old,

• Patient treated in the Nuclear Medicine Department for the treatment by metabolic radiotherapy,

• Patient treated 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological collection	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 Ancillary study : For metastatic thyroïd cancer and neuroendocrine tumor : anapath blocks of the initial diagnosis will be archived and dosimetric data will be collected for the cycle 1 For neuroendocrine tumor : blood sample additionnal will be realized at the cycle 1 (pre and post treatment)
Biological collection	tumor 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 Ancillary study : For metastatic thyroïd cancer and neuroendocrine tumor : anapath blocks of the initial diagnosis will be archived and dosimetric data will be collected for the cycle 1 For neuroendocrine tumor : blood sample additionnal will be realized at the cycle 1 (pre and post treatment)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Hopital Haut Lévêque; 🇫🇷 Bordeaux, Aquitaine, France

Hôpital LaTimone; 🇫🇷 Marseille, Bouches Du Rhône, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Institut Universitaire du Cancer de Toulouse; 🇫🇷 Toulouse, France