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| Name | Class |
|---|---|
| IDEOGEN | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detection of circulating tumoral DNA | Blood assessment to detect circultating tumoral DNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| circulating tumoral DNA detection | Other | blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with newly or relapse/refractory peripheral T Cell Lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Camus | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Rouen | France |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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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 |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |