Trial · NCT06841705
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Steroid-free remission rate | 8 weeks | Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication. |
| Secondary | Steroid-free remission rate | 5 weeks | Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication. |
| Secondary | Change in calprotectin | 0, 2, 5 and 8 weeks | As compared to baseline |
| Secondary | Cumulative steroid exposure | 5 weeks and 8 weeks | Steroid dose x Duration of treatment |
| Secondary | Time to steroid-free colitis remission | Up to 12 months | Defined as the time from the first day of treatment to the first day with less than 10 mg of prednisone/day and grade 1 or lower symptoms. |
| Secondary | Rate of secondary immunosuppression for management of ICI colitis | 5 weeks and 8 weeks | Defined as the use of open-label prednisone or biologic rescue medication |
| Secondary | Rate of symptomatic remission | 5 weeks and 8 weeks | Defined as a reduction in stool frequency to \< 4 bowel movements/day at 1 week |
| Secondary | Hospitalization rate | 8 weeks | Due to colitis |
| Secondary | Rates of colectomy | 8 weeks | Due to colitis |
| Secondary | Endoscopic resolution of colitis | 8 weeks | Rate of endoscopic resolution of colitis will be determined, if endoscopy is performed at 8 weeks |
| Secondary | Best overall cancer response | 8 weeks and 12 months | |
| Secondary | Overall survival | Time of death or 12 months | Defined as time from the first day of protocol treatment to death or last contact date. |
| Secondary | Proportion of participants with an adverse event (AE) | 5 weeks | Proportion of participants with an AE through week 5 (±5 days) attributable to ICI colitis treatment |
| Secondary | Proportion of participants with an AE | 8 weeks | Proportion of participants with an AE through week 8 (±5 days) attributable to ICI colitis treatment |
| Secondary | Presence of histologic inflammation | 0, 8 weeks | |
| Secondary | Pattern of histologic inflammation | 0, 8 weeks | Categorized as: Active Colitis Pattern, Lymphocytic Pattern, Graft Vs Host Disease Pattern, Mixed Pattern. |
| Other | Time to resumption of cancer treatment | 12 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06841705/registered