Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT06807593
Brief Summary:
The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.
Detailed Description:
Primary Objectives:
To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis
To assess the efficacy of ustekinumab in reducing fecal calprotectin levels
Secondary Objectives:
To assess steroid free IMDC remission by week 4 and 8
To assess the IMDC recurrence by week 4 and 8
To assess the time duration to IMDC recurrence and overall survival
To assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis
To identify immune signatures related to GI irAEs and those specific to responsiveness to ustekinumab
To identify pro-inflammatory immune signatures in serum
To assess patient symptom and QOL
Study:
NCT06807593
Study Brief:
Protocol Section:
NCT06807593