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

Sponsor

Centre Henri Becquerel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06089941

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral T Cell Lymphoma	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 Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Nov 2, 2025

Anticipated Study Completion Date :

Nov 2, 2026

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Feasibility of ctDNA assessement [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%.
Feasibility of ctDNA assessement [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%.
Feasibility of ctDNA assessement [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.).