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

NCT ID: NCT06357871

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-28

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Chemotherapeutic Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Test cohort

To establish the score

No intervention

Intervention Type OTHER

No intervention

Validation cohort

To validate the score

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

CHU de Reims

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrien Flahault, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Nancy

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Adrien Flahault, MD, PhD

Role: CONTACT

+33 3 83 15 31 69

Facility Contacts

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Adrien Flahault, MD PhD

Role: primary

0383858585

Other Identifiers

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2023PI178

Identifier Type: -

Identifier Source: org_study_id

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