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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104529
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 28, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jean-Pierre BLEUSE, MD 0467613102 ext +33 DRCI-icm105@icm.unicancer.fr

Locations
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France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066    marc.ychou@icm.unicancer.fr   
Contact: Jean-Pierre BLEUSE    0467613102    jean-pierre.bleuse@icm.unicancer.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Emmanuel DESHAYES, MD Institut régional du Cancer Montpellier
Publications:
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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04104529    
Other Study ID Numbers: PROICM 2019-10 BRI
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
thyroid cancer
prostate cancer
neuroendocrine tumors
nuclear medecine
Additional relevant MeSH terms:
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Prostatic Neoplasms
Thyroid Neoplasms
Neuroendocrine Tumors
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue