Plasma cell-free DNA in children with ALL to help monitor disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores whether plasma cell-free DNA (cfDNA) can serve as a noninvasive biomarker for monitoring minimal residual disease in pediatric ALL. Researchers will collect biological samples and compare cfDNA results with traditional bone marrow–based assessments to see if cfDNA reflects overall tumor burden and treatment response. The study targets children under 18 with newly diagnosed B- or T-cell ALL who lack BCR-ABL1 rearrangement, enrolling before beginning corticosteroids or chemotherapy. A control population includes patients undergoing blood sampling for HLA typing or siblings of leukemia patients. The study aims to determine feasibility, correlation with established MRD measures, and potential to enable more frequent monitoring with less invasive procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

ALL population

* Age \< 18 years
* Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia
* Absence of BCR::ABL1 rearrangement
* For infants (\<12 months), absence of KMT2A rearrangement
* Inclusion before initiation of corticosteroid therapy or chemotherapy
* Written informed consent from legal guardians
* Affiliation to a national health insurance system Control population
* Age \< 18 years
* Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation
* Sibling of a patient with leukemia
* Written informed consent from legal guardians
* Affiliation to a national health insurance system

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Patients not affiliated with a health insurance system

Where it's running

• Hôpital Armand Trousseau
  Paris, France Recruiting
• Hôpital Robert Debré
  Paris, France Recruiting

Study contacts

• Study coordinator: Marion Strullu, MD PhD
• Email: marion.strullu@aphp.fr
• Phone: +330140035388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.