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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04104529
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emmanuel DESHAYES, MD
Principal Investigator Affiliation Institut régional du Cancer Montpellier
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Thyroid Cancer, Prostate Cancer, Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

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 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)

Interventions

Other: - Biological collection

The biological collection will also include samples of blood samples collected before and during treatment.

Other: - tumor collection

Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hopital Haut Lévêque, Bordeaux, Aquitaine, France

Status

Recruiting

Address

Hopital Haut Lévêque

Bordeaux, Aquitaine,

Site Contact

Elif HINDIE, MD

[email protected]

0467613102

Hôpital LaTimone, Marseille, Bouches Du Rhône, France

Status

Not yet recruiting

Address

Hôpital LaTimone

Marseille, Bouches Du Rhône,

Site Contact

David TAIEB, MD

[email protected]

0467613102

Montpellier, France

Status

Recruiting

Address

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , 34298

Site Contact

Marc Ychou, MD, PhD

[email protected]

33-4-6761-3066

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