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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05803616
Other study ID # 2021-01016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source University Hospital, Geneva
Contact Noemie Lang, MD
Phone +41795532406
Email noemie.lang@hcuge.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 (e.g.) 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.


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 slices/blocks at ILD diagnosis from Pathology Departments of participating Centers for retrospective ILD subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Any patient with a diagnosis of ILD defined by the World Health Organization (WHO HAEM 5)(e.g. post-transplant setting, X-link, concomitant auto-immune disorders) Exclusion Criteria: - Lymphoproliferative disorders non immune-mediated - Lymphoproliferative disorders occurring in the context of a concomitant human immunodeficiency virus (HIV) infection

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Liquid biopsy
ctDNA measured in the plasma and analyse by next generation sequencing (NGS) for minimal residual disease (MRD)

Locations

Country Name City State
Switzerland Basel University Hospital Basel
Switzerland Oncology Institute of Southern Switzerland Bellinzona
Switzerland Inselspital Bern
Switzerland Hôpitaux Universitaires de Genève (HUG) Geneva
Switzerland Kantonsspital St Gallen
Switzerland University Hospital Zu¨rich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive value of ctDNA to monitor response in ILD (MRD) using NGS Molecular response (minimal residual disease, MRD) during therapy in ILD diagnosed patients will be monitored using regular liquid biopsy (ctDNA) and assessing the presence or not of genomic aberrations present at baseline if any. 2 years
Secondary Characterisation of ILD tumour microenvironment and genetic / epigenetic landscape Tumour microenvironment and genetic / epigenetic landscape will be explored using various techniques such as NGS, multiplex immunohistochemistry, digital droplet Polymerase Chain Reaction (ddPCR) and methyloma assays. 2 years
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