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Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer

NCT06357871 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-04-10

No results posted yet for this study

Summary

Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.

Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.

We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.

Conditions

  • Chemotherapeutic Toxicity

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • CHU de Reims

    collaborator OTHER

  • Centre Hospitalier Régional Metz-Thionville

    collaborator OTHER

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Adrien Flahault, MD, PhD · CHRU de Nancy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357871 on ClinicalTrials.gov