Blood ctDNA testing to monitor treatment in children and young adults with classical Hodgkin lymphoma
Non-interventional Research Protocol Involving Human Participants
This project tests whether a blood test that detects circulating tumor DNA can monitor treatment response and help predict relapse in children and young adults with classical Hodgkin lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Paris) |
| Trial ID | NCT07356882 on ClinicalTrials.gov |
What this trial studies
This observational European project uses plasma-based circulating tumor DNA (ctDNA) analysis as a non-invasive biomarker in pediatric classical Hodgkin lymphoma. Blood samples will be collected at diagnosis and during therapy to detect recurrent mutations and measure molecular tumor burden, with results compared to PET/CT and clinical outcomes. The aim is to refine risk stratification by identifying patients at higher risk of relapse early and those who might safely receive less intensive therapy. The project is nested in pediatric cooperative networks and uses centralized molecular testing with planned long-term follow-up.
Who should consider this trial
Good fit: Children and young adults under 25 with newly diagnosed classical Hodgkin lymphoma who can provide consent and be followed at participating centers are the ideal candidates.
Not a fit: Patients with nodular lymphocyte predominant Hodgkin lymphoma, prior chemotherapy/radiotherapy for another cancer, or those living outside participating countries where follow-up cannot be ensured are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this approach could identify high-relapse patients earlier and guide more personalized therapy to reduce overtreatment and long-term side effects.
How similar studies have performed: Similar ctDNA approaches have shown feasibility and prognostic value in adult cHL and early pediatric pilot work (e.g., the HOLY study) with high baseline mutation detection and correlation with PET/CT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed classical Hodgkin lymphoma (cHL) * Children and young adults under the age of 25 years old * Signature of informed consent by the patient and/or holders of parental authority (depending on the age of the patient) * Affiliation to a social security scheme or being beneficiary of such a scheme Exclusion Criteria: * Previous treatment with chemotherapy or radiotherapy for another cancer * Pretreatment of Hodgkin lymphoma (except one treatment with corticosteroid for 7 to 10 days for large or compressive mediastinal tumors). * Diagnosis of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) * Other concomitant malignancies • Residence outside participating countries in for which long-term follow-up cannot be ensured
Where this trial is running
Paris
- Pediatric Hematology and Oncology Department — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mathieu SIMONIN, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Mathieu SIMONIN, Medical Doctor
- Email: mathieu.simonin@aphp.fr
- Phone: 00 33 1 44 73 66 04
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.