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Active, Not Recruiting

NCT Number: NCT06089941

Circulating Tumor DNA Sequencing in Patients With 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

circulating tumoral DNA detection

Other

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

Primary outcomes

  1. Feasibility of ctDNA assessement

    Time frame: at the inclusion

    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%.

  2. Feasibility of ctDNA assessement

    Time frame: 8 weeks

    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%.

  3. Feasibility of ctDNA assessement

    Time frame: 16 weeks

    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%.

Secondary outcomes

  1. Concordance between ctDNA and tumor mutational profile

    Time frame: at the inclusion

    Description of the concordance between the mutational profile on the tumor and on plasma ctDNA at diagnosis and at relapse

  2. Progression free survival

    Time frame: one year

    Time beetween inclusion and progression

  3. Overal survival

    Time frame: one year

    Time beetween inclusion and death

  4. Imaging assessment by PET-CT

    Time frame: 16 weeks

    Description of metabolic tumor volume before treatment, and therapeutic response (based on Lugano 2014 criteria) end of treatment

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Collaborators

  • IDEOGEN

Registry information

Official study title

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

Acronym: PTCL-SEQ

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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