Involvement of the Immune System in Intrinsic Radiosensitivity

NCT06826066 | Recruiting

• 1 other identifier: APHP240671
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and ensuring both local and systemic tumor control. As a result, current treatments are highly effective, providing, for instance, a 5-year overall survival rate of about 90%-95% for localized breast and prostate cancers.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Identify immunological markers predictive of intrinsic radiosensitivity.

  Identification of immunological markers predictive of intrinsic radiosensitivity using flow cytometry analysis

  48 hours

Study Arms (1)

TRANSPROUST is a prospective, single-center cohort.

EXPERIMENTAL

Other: Blood samples

Interventions

Blood samples OTHER

We propose to include patients who have been treated with radiotherapy and did not experience severe radiation-induced toxicity, after obtaining their informed consent. A blood sample will then be collected by the nursing staff from the Oncology-Radiotherapy department at Henri Mondor University Hospital. After the patient signs the consent form, each patient will have their clinical information recorded and a blood sample taken. The blood samples will be immediately transported, at room temperature, to the INSERM U955 i-Biot unit at Henri Mondor (serum, plasma, and PBMC). All samples will be frozen at -80°C for later analysis.

TRANSPROUST is a prospective, single-center cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients who have been treated with radiotherapy
• Absence of toxicity grade 2 or higher
• Patients without psychiatric, sociological, family, or geographical difficulties that could interfere with patient compliance to the protocol or follow-up
• Information and signed informed consent
• Affiliated with social security

You may not qualify if:

• Inability to obtain patient consent
• Patient refusing blood sample collection
• Patient deprived of liberty or under legal protection (under guardianship, under curatorship)
• Patients who have experienced radiation-induced toxicity of grade 2 or higher
• Disease progression, relapse
• Patient under State Medical Aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Henri Mondor, 1 rue Gustave Eiffel,

Créteil, Île-de-France Region, 94000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

BELKACIMI Mr Yazid, PhD

CONTACT

01 49 81 45 22; yazid.belkacemi@aphp.fr

DEBBI Mr Kamel, Dr

CONTACT

01 49 81 45 22; kamel.debbi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 13, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): May 12, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)