circulating tumoral DNA detection: blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.).
Primary outcome measure(s)
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%.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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