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

NCT06357871 | Unknown

• 1 other identifier: 2023PI178
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI

  between January 2020 and December 2024

Study Arms (2)

Test cohort

To establish the score

Other: No intervention

Validation cohort

To validate the score

Other: No intervention

Interventions

No intervention OTHER

No intervention

Test cohort; Validation cohort

Eligibility Criteria

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

Study Population

The study will include all patients hospitalized for kidney biopsy in the context of acute renal failure with CPI treatment.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University Hospital, Strasbourg, France: collaborator
• CHU de Reims: collaborator
• Centre Hospitalier Régional Metz-Thionville: collaborator
• European Georges Pompidou Hospital: collaborator

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Study Officials

• Adrien Flahault, MD, PhD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien Flahault, MD, PhD

CONTACT

+33 3 83 15 31 69; a.flahault@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: November 28, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)