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

NCT06089941 | Active Not Recruiting

• 1 other identifier: CHB23.03
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral T Cell Lymphoma

Keywords

peripheral T Cell Lymphoma; Next generation sequencing; circulating tumor DNA; Low-pass whole genome sequencing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Concordance between ctDNA and tumor mutational profile

  at the inclusion

• Progression free survival

  one year

• Overal survival

  one year

• Imaging assessment by PET-CT

  16 weeks

Study Arms (1)

Detection of circulating tumoral DNA

Blood assessment to detect circultating tumoral DNA

Other: circulating tumoral DNA detection

Interventions

circulating tumoral DNA detection OTHER

blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse

Detection of circulating tumoral DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with newly or relapse/refractory peripheral T Cell Lymphoma

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Henri Becquerel: lead
• IDEOGEN: collaborator

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Vincent Camus

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2024
• Primary Completion: November 4, 2025
• Study Completion (Estimated): November 4, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)