Liquid Biopsy to Enable Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders

NCT05803616 | Unknown DMC

• 1 other identifier: 2021-01016
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 6

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 (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.

Conditions

Lymphoproliferative Disorders; Lymphoproliferative Disorder Following Transplantation

Keywords

Immune-related Lymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characterisation of ILD tumour microenvironment and genetic / epigenetic landscape

  2 years

Study Arms (1)

ILD group

All patients newly diagnosed or relapsing from an ILD could be enrolled in this observational study

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

ctDNA measured in the plasma and analyse by next generation sequencing (NGS) for minimal residual disease (MRD)

ILD group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients newly diagnosed or relapsing from an ILD as per World Health Organization (WHO HAEM 5) classification

You may qualify if:

• 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)

You may not qualify if:

• Lymphoproliferative disorders non immune-mediated
• Lymphoproliferative disorders occurring in the context of a concomitant human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (6)

Basel University Hospital

Basel, Switzerland

NOT YET RECRUITING

Oncology Institute of Southern Switzerland

Bellinzona, Switzerland

NOT YET RECRUITING

Inselspital

Bern, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205, Switzerland

RECRUITING

Kantonsspital

Sankt Gallen, Switzerland

NOT YET RECRUITING

University Hospital Zürich

Zurich, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood 20 ml at each time point defined as per protocol

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Noemie Lang, MD

  Geneva Univresity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemie Lang, MD

CONTACT

+41795532406; noemie.lang@hcuge.ch

Jerome Tamburini-Bonnefoy, Prof

CONTACT

+41795530947; jerome.tamburini-bonnefoy@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 7, 2023
• Study Start: May 23, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available one month after study results publication with no limit of time.
• Access Criteria: All data supporting the findings of the current study will be made available from the corresponding author upon reasonable scientific request

Locations

CH (6)