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

Recruiting
Conditions
Chemotherapeutic Toxicity
Interventions
Other: No intervention
Registration Number
NCT06357871
Lead Sponsor
Central Hospital, Nancy, France
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Patient over 18 years old Diagnosis of solid cancer treated by immunotherapy such as checkpoint inhibitor, associated or not with chemotherapy Renal failure having benefited from a renal biopsy
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Test cohortNo interventionTo establish the score
Validation cohortNo interventionTo validate the score
Primary Outcome Measures
NameTimeMethod
Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPIbetween January 2020 and December 2024
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHRU de Nancy

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Vandoeuvre les nancy, France

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