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

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ClinicalTrials.gov Identifier: NCT05803616
Recruitment Status : Recruiting
First Posted : April 7, 2023
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
Noémie Lang, University Hospital, Geneva

Study Description
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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.


Condition or disease Intervention/treatment
Lymphoproliferative Disorders Lymphoproliferative Disorder Following Transplantation Diagnostic Test: Liquid biopsy

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

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liquid Biopsy-based Genomic Assay to Enable Non-invasive Precision Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders (ILD)
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
ILD group
All patients newly diagnosed or relapsing from an ILD could be enrolled in this observational study
 Diagnostic Test: Liquid biopsy
ctDNA measured in the plasma and analyse by next generation sequencing (NGS) for minimal residual disease (MRD)


Outcome Measures
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Primary Outcome Measures :
  1. Predictive value of ctDNA to monitor response in ILD (MRD) using NGS [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Characterisation of ILD tumour microenvironment and genetic / epigenetic landscape [ Time Frame: 2 years ]
    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.


Biospecimen Retention:   Samples With DNA
Blood 20 ml at each time point defined as per protocol

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05803616


Contacts
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Contact: Noemie Lang, MD +41795532406 noemie.lang@hcuge.ch
Contact: Jerome Tamburini-Bonnefoy, Prof +41795530947 jerome.tamburini-bonnefoy@hcuge.ch

Locations
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Switzerland
Basel University Hospital Not yet recruiting
Basel, Switzerland
Contact: Fatime Krasniqi    +41 61 265 50 74    fatime.krasniqi@usb.ch   
Oncology Institute of Southern Switzerland Not yet recruiting
Bellinzona, Switzerland
Contact: Alden Moccia    +41 (0)91 811 35 11    Alden.Moccia@eoc.ch   
Inselspital Recruiting
Bern, Switzerland
Contact: Urban Novak    +41 (0)31 632 5668    urban.novak@insel.ch   
Hôpitaux Universitaires de Genève (HUG) Recruiting
Geneva, Switzerland, 1205
Contact: Noémie Lang    +41795532406    noemie.lang@hcuge.ch   
Kantonsspital Not yet recruiting
St Gallen, Switzerland
Contact: Martin Fehr    +41 71 494 29 22    Martin.fehr@kssg.ch   
University Hospital Zürich Not yet recruiting
Zürich, Switzerland
Contact: Wiebke Rösler    +41 44 255 37 82    Wiebke.Roesler@usz.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Noemie Lang, MD Geneva Univresity Hospital
More Information
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Responsible Party: Noémie Lang, DR, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT05803616    
Other Study ID Numbers: 2021-01016
First Posted: April 7, 2023    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All anonymised IPD that underlie results in a publication will be shared upon request with other researchers.

Types of supporting information that will be shared, in addition to the individual participant data set and data dictionaries will include the study protocol, informed consent form and clinical study report
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noémie Lang, University Hospital, Geneva:
Immune-related Lymphoproliferative Disorders
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases