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

Prostate Cancer Clinical Trial

— BCB RIV  

Official title:

Establishment of a Prospective Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104529
• Other study ID #: PROICM 2019-10 BRI
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: October 2026

Study information

• Verified date: June 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Aurore MOUSSION
• Phone: 0467613102
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Prostate Cancer
• Prostatic Neoplasms
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Other:
• Biological collection
The biological collection will also include samples of blood samples collected before and during treatment.
• tumor collection
Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (24)

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Wu HX, Zhong H, Xu YD, Xu CP, Zhang Y, Zhang W. Psychological and behavioral intervention improves the quality of life and mental health of patients suffering from differentiated thyroid cancer treated with postoperative radioactive iodine-131. Neuropsychiatr Dis Treat. 2016 May 2;12:1055-60. doi: 10.2147/NDT.S105460. eCollection 2016. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who gave their consent to participate in the study	The proportion of patients who consent to participate in the study among the screened patients	Until the study completion: 5 years