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

Last updated: April 21, 2023
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT05803616
2021-01016
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 20
Study Start date:
May 23, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Basel University Hospital

    Basel,
    Switzerland

    Site Not Available

  • Oncology Institute of Southern Switzerland

    Bellinzona,
    Switzerland

    Site Not Available

  • Inselspital

    Bern,
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1205
    Switzerland

    Active - Recruiting

  • Kantonsspital

    St Gallen,
    Switzerland

    Site Not Available

  • University Hospital Zürich

    Zürich,
    Switzerland

    Site Not Available

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