Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362148
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-08
Brief Title:
Circulating Tumor DNA in Peripheral T-cell Lymphomas
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Next-Generation Sequencing-based Tumor- and Plasma-informed Droplet Digital PCR Assay for Detection of Circulating Tumor DNA in Peripheral T-cell Lymphomas
Status:
RECRUITING
Status Verified Date:
2024-03
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:
CIRCULATE
Brief Summary:
The aim of this study is to evaluate the feasibility of circulating tumor DNA ctDNA measurement in blood plasma for the applicability in prognostication treatment evaluation and measurable residual disease MRD surveillance in a cohort of patients with newly diagnosed or relapsedrefractory peripheral T-cell lymphomas PTCL
Detailed Description:
In this observational prospective cohort study the investigators want to test the use of minimal-invasive liquid biopsies blood plasma for the detection of ctDNA in patients with newly diagnosed or relapsedrefractory PTCL In each enrolled patient a diagnostic tumor-containing tissue biopsy as well as a baseline plasma sample will be subject to targeted next-generation sequencing NGS with the aim of identifying tumor-specific genetic alterations and clonal T-cell receptor rearrangements This testing will be performed on biopsies that have been obtained as a part of standard-of-care diagnostic evaluation for PTCL and no further invasive biopsies will be performed
Based on the NGS-analysis a droplet digital polymerase chain reaction ddPCR assay will be designed for each patient ddPCR will be used to detect ctDNA in plasma at diagnosis and later at defined time points during treatment and in the follow-up period
At the same defined time points PETCT scans will be performed for later comparative analysis PTCL patients routinely have PETCT scans performed before the start of treatment mid-treatment at the end of treatment and after hematopoietic stem cell transplant when applicable PETCT scans will be conducted every 6 months for the first 2 years of routine follow-up
Active patient participation ie blood sampling for ctDNA analysis and PETCT scans is expected to last up to 27 months from inclusion Follow-up for survival analysis will be done for up to 5 years from inclusion
The investigators hypothesize that the NGS-based tumor- and plasma-informed ddPCR assay applied in this study will provide a highly sensitive and specific tool for prognostication response evaluation and detection of relapse in patients with PTCL
Based on the NGS-analysis a droplet digital polymerase chain reaction ddPCR assay will be designed for each patient ddPCR will be used to detect ctDNA in plasma at diagnosis and later at defined time points during treatment and in the follow-up period
At the same defined time points PETCT scans will be performed for later comparative analysis PTCL patients routinely have PETCT scans performed before the start of treatment mid-treatment at the end of treatment and after hematopoietic stem cell transplant when applicable PETCT scans will be conducted every 6 months for the first 2 years of routine follow-up
Active patient participation ie blood sampling for ctDNA analysis and PETCT scans is expected to last up to 27 months from inclusion Follow-up for survival analysis will be done for up to 5 years from inclusion
The investigators hypothesize that the NGS-based tumor- and plasma-informed ddPCR assay applied in this study will provide a highly sensitive and specific tool for prognostication response evaluation and detection of relapse in patients with PTCL
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