NCT06089941

Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas

Prospective Study of Circulating Tumor DNA Sequencing in Peripheral T-cell Lymphomas

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL).

Detailed description

Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of diseases resulting from the clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas and patients with these lymphomas have among the worst 5-year relative survivals (36%-56%, depending on prognostic factors). There are no biomarkers validated in PTCL. Low pass whole genome sequencing (lpWGS) is an innovative molecular biology technique capable of detecting variations in the number of gene copies in patients' blood, which is a reflection of the quantity of tumor cells in the patient, lymphoma cells carrying numerous gains and deletions of certain genes at the somatic level. lpWGS is inexpensive, requires small quantities of DNA, targets the entire genome, is less time-consuming than other techniques for studying ctDNA and preliminary data in lymphomas have shown the interest of this technique. The investigators hypothesize that this study of ctDNA in PTCL will be relevant, sensitive and very informative for monitoring patients with the lpWGS technique combined with a panel of genes targeted in depth by NGS that the investigators propose to implement. This is a multicenter, prospective study, based on biological samples and clinical and imaging data to be collected. This study will be offered to each patient suffering from PTCL, including T/NK lymphomas (NKTL) with systemic involvement (excluding cutaneous T-cell lymphomas) having an indication for systemic treatment.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
OTHER	circulating tumoral DNA detection	blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-11-04
• Completion: 2026-11-04
• First posted: 2023-10-19
• Last updated: 2026-02-20

Locations

1 site across 1 country: France