Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089941
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-10-09
Brief Title:
Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas
Sponsor:
Centre Henri Becquerel
Organization:
Centre Henri Becquerel
Study Overview
Official Title:
Prospective Study of Circulating Tumor DNA Sequencing in Peripheral T-cell Lymphomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTCL-SEQ
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 relapsedrefractory peripheral T-cell lymphoma PTCL
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 TNK lymphomas NKTL with systemic involvement excluding cutaneous T-cell lymphomas having an indication for systemic treatment
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 TNK lymphomas NKTL with systemic involvement excluding cutaneous T-cell lymphomas having an indication for systemic treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None