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NCT05102773 · ClinicalTrials.gov registry record
The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients
A clinical trial of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Pathologic Stage IV Cutaneous Melanoma AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- 88
- Enrollment target
- 1
- Study location
NCT05102773: Completed study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Pathologic Stage IV Cutaneous Melanoma AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
NCT05102773 is a study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Pathologic Stage IV Cutaneous Melanoma AJCC v8 that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 88 participants, below the 149-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05102773, a study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Pathologic Stage IV Cutaneous Melanoma AJCC v8, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. Gut microbiome plays a critical role in response to immune checkpoint inhibitors. Studying the change in an individual's microbiome due to corticosteroid use may help researchers to determine whether an individual's microbiome can predict their response and toxicity to immune checkpoint inhibitors.
Primary Outcome
This analysis will follow a logistic regression structure. The dependent variable, response to treatment, will be evaluated using standardized criteria (Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1). Each patient will be classified as "respond", "stable" or "progression'' as a categorical variable and then binarized, with "respond" or "stable" in the category "responders", and "progression" in the category "non-responders". Independent variables will be alpha-diversi
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2022-05-05 |
What the finished NCT05102773 record still lists
NCT05102773 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 149-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05102773 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05102773 about?
NCT05102773 is a clinical study titled "The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients". This pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. Gut microbiome plays a critical role in response to immune checkpoint inhibitors. Studying the change in an individual's microbiome due to c...
What is the current status of trial NCT05102773?
This trial is currently completed. The enrollment target is 88 participants. The study started on 2020-02-10. Estimated completion is 2022-05-05.
What conditions does trial NCT05102773 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT05102773?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT05102773?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05102773 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05102773's enrollment target sits among peer trials
88 13th of 32 higher than 20 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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