Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas (PTCL-SEQ)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Other: circulating tumoral DNA detection

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patient with newly or relapse/refractory peripheral T Cell Lymphoma

Description

Inclusion Criteria:

• Aged 18 or over
• Newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL), including T/NK lymphoma (NKTL)
• Pre-therapeutic FDG PET-CT already performed
• Signed informed consent
• Patients affiliated with or beneficiaries of a health insurance plan

Exclusion Criteria:

• Cutaneous T-cell lymphomas without systemic involvement
• Pregnant or breastfeeding women
• For newly diagnosed patients: patient who has already started the first systemic treatment for their lymphoma (apart from pre-phase corticosteroid therapy which is authorized)
• For patients in a relapsed/refractory situation: Patient who has already started the new specific line of lymphoma treatment planned for the current relapsed/refractory situation (apart from pre-phase corticosteroid therapy which is authorized)
• Lack of patient consent
• Patient whose weight is less than 30 kg
• Protected adult or deprived of freedoms (under guardianship or curatorship)
• Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Detection of circulating tumoral DNA; Blood assessment to detect circultating tumoral DNA	Other: circulating tumoral DNA detection; blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of ctDNA assessement	rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.	at the inclusion
Feasibility of ctDNA assessement	rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.	8 weeks
Feasibility of ctDNA assessement	rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between ctDNA and tumor mutational profile	Description of the concordance between the mutational profile on the tumor and on plasma ctDNA at diagnosis and at relapse	at the inclusion
Progression free survival	Time beetween inclusion and progression	one year
Overal survival	Time beetween inclusion and death	one year
Imaging assessment by PET-CT	Description of metabolic tumor volume before treatment, and therapeutic response (based on Lugano 2014 criteria) end of treatment	16 weeks

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Collaborators: IDEOGEN
• Investigators: Principal Investigator: Vincent Camus, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 4, 2025
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: circulating tumor DNA; Next generation sequencing; peripheral T Cell Lymphoma; Low-pass whole genome sequencing
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: CHB23.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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