How the immune system affects a person's sensitivity to radiotherapy.
Involvement of the Immune System in Intrinsic Radiosensitivity
This project tests whether differences in patients' immune cells are linked to who does or does not develop severe side effects after radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Créteil, Île-de-France Region) |
| Trial ID | NCT06826066 on ClinicalTrials.gov |
What this trial studies
The effort builds a control cohort (TRANSPROUST) of patients treated with radiotherapy who did not develop severe toxicity and pairs their clinical, dosimetric, and blood-based biological data with an existing registry of radiosensitive patients (PROUST). Participants provide blood samples that will be analyzed for cellular and molecular immune markers. Immune profiles will be compared alongside treatment dose and volume data to try to separate treatment-related from patient-intrinsic causes of toxicity. The aim is to identify immune-related signatures that explain or predict intrinsic radiosensitivity.
Who should consider this trial
Good fit: Adults aged 18 or older who have been treated with radiotherapy, did not experience grade 2 or higher radiation toxicity, can give informed consent, and are covered by social security are ideal candidates.
Not a fit: Patients who have already experienced grade 2 or higher radiation toxicity, have active disease progression or relapse, cannot consent, or are under legal protection are unlikely to receive direct benefit from this control-focused project.
Why it matters
Potential benefit: If successful, this could lead to tests that predict who is at higher risk for severe radiation side effects and help personalize radiotherapy to reduce harm.
How similar studies have performed: Some prior research suggests immune responses influence radiation outcomes, but prospective registry-based immune monitoring to pinpoint cellular causes of radiosensitivity remains relatively novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil, Île-de-France Region
- Hôpital Henri Mondor, 1 rue Gustave Eiffel, — Créteil, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: BELKACIMI Mr Yazid, PhD
- Email: yazid.belkacemi@aphp.fr
- Phone: 01 49 81 45 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.