Involvement of the Immune System in Intrinsic Radiosensitivity (TRANSPROUST)

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Other: Blood samples

Detailed Description

In everyday clinical practice, the indications for radiotherapy are based on the benefit-to-risk ratio concerning toxicity. In most cases, radiotherapy causes mild to moderate acute or late side effects, depending on the patient and the volumes irradiated. However, in 1% to 5% of treated patients, these side effects can be severe, unexpected, and often unexplained. The cause of this toxicity remains poorly understood and largely unexplored, especially concerning the intrinsic radiosensitivity of patients.

The PROUST study (French Registry for Review of Morbidity and Mortality; RMM) was initiated in France to prospectively collect clinical, dosimetric, and biological data on individual radiosensitivity in patients who experience severe radiation-induced toxicity. The goal of this study is to better characterize patients with severe radiation-induced toxicities and identify the cellular factors involved in this toxicity.

Although the aim is to identify the cellular and molecular immune factors involved in severe radiation-induced toxicity, we currently cannot determine whether the immune monitoring observed in radiosensitive patients is a consequence of the toxicity itself or of radiotherapy. To answer this question, we have decided to create a control cohort, called TRANSPROUST, which includes patients treated with radiotherapy but who did not experience severe radiation-induced toxicity. After obtaining consent from patients who were treated with radiotherapy but did not develop severe toxicity, we will collect blood samples similar to those taken from the severe toxicity cohort.

These samples will undergo flow cytometry analysis, and the results will be compared with those of patients included in the PROUST cohort.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BELKACIMI Mr Yazid, PhD; Phone Number: + 33 01 49 81 45 22; Email: yazid.belkacemi@aphp.fr
• Study Contact Backup: Name: DEBBI Mr Kamel, Dr; Phone Number: +33 01 49 81 45 22; Email: kamel.debbi@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Créteil, Île-de-France Region, France, 94000
      • Recruiting
      • Hôpital Henri Mondor, 1 rue Gustave Eiffel,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TRANSPROUST is a prospective, single-center cohort.

Other: Blood samples; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify immunological markers predictive of intrinsic radiosensitivity.	Identification of immunological markers predictive of intrinsic radiosensitivity using flow cytometry analysis	48 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): May 12, 2027

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: APHP240671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATA IS OWNED BY ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No