Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05803616
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2023-03-09
Brief Title:
Liquid Biopsy to Enable Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Liquid Biopsy-based Genomic Assay to Enable Non-invasive Precision Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders ILD
Status:
RECRUITING
Status Verified Date:
2023-04
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:
LIMPID
Brief Summary:
Immune-mediated lymphoproliferative disorders ILD as per World Health Organization WHO HAEM 5 classification are rare conditions associated with a poor outcome Current management of ILD is focusing on prevention eg early detection of ILD with preemptive Epstein Barr virus EBV Deoxyribonucleic acid DNA levels monitoring however this approach is useless for the early detection of EBV-negative ILD Therapeutic management consists of a reduction in immunosuppressive therapy RIS allowing mostly partial and transient responses Rituximab an anti-CD20 cluster differentiation 20 antibody provides roughly 20-25 of complete and durable responses thus the majority of ILD patients will require immunochemotherapy burden with significant toxicity in this challenging population Implementation of liquid biopsy also called circulating tumor DNA ctDNA in plasma or serum is an area of investigation that is becoming increasingly relevant for clinical practice allowing for non-invasive monitoring of disease status
Early detection and monitoring of ILD using ctDNA may allow for preemptive therapy improved risk-stratification and ultimately lead to outcome improvement This multicenter Swiss project will allow a better understanding of ILD mutational landscape and pathogenesis which could lead to the development of new screening and monitoring approaches for patients suffering from ILD
Early detection and monitoring of ILD using ctDNA may allow for preemptive therapy improved risk-stratification and ultimately lead to outcome improvement This multicenter Swiss project will allow a better understanding of ILD mutational landscape and pathogenesis which could lead to the development of new screening and monitoring approaches for patients suffering from ILD
Detailed Description:
In this observational prospective study the investigators will collect clinical data from subjects charts through a dedicated multicenter electronic case report form eCRF
Whenever available PET-CT will be transferred through a Web-based Imaging and Diagnosis Exchange Network WIDEN to perform a blinded independent review of staging and response
Biological samples included 20 ml of blood collected at each of the following planned clinical points in time i at ILD diagnosis ii after first cycle of therapy iii at interim response assessment iv at the end-of-treatment v at 3 months follow-up vi at 12 months follow-up vii at disease progression if applicable Additional samples could be collected if clinically relevant
Additionally the investigators will request formalin-fixed and paraffin-embedded tissue FFPET or fresh-frozen FF tissue slicesblocks at ILD diagnosis from Pathology Departments of participating Centers for retrospective ILD subjects
Whenever available PET-CT will be transferred through a Web-based Imaging and Diagnosis Exchange Network WIDEN to perform a blinded independent review of staging and response
Biological samples included 20 ml of blood collected at each of the following planned clinical points in time i at ILD diagnosis ii after first cycle of therapy iii at interim response assessment iv at the end-of-treatment v at 3 months follow-up vi at 12 months follow-up vii at disease progression if applicable Additional samples could be collected if clinically relevant
Additionally the investigators will request formalin-fixed and paraffin-embedded tissue FFPET or fresh-frozen FF tissue slicesblocks at ILD diagnosis from Pathology Departments of participating Centers for retrospective ILD subjects
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