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NCT04990726 · ClinicalTrials.gov registry record
Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors
A clinical trial of Clinical Stage III Cutaneous Melanoma AJCC v8 and Melanoma Stage IV, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- 126
- Enrollment target
- 1
- Study location
NCT04990726: Active study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Melanoma Stage IV, sponsored by M.D. Anderson Cancer Center.
NCT04990726 is a study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Melanoma Stage IV that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 126 participants, below the 237-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04990726, a study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Melanoma Stage IV, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.
Primary Outcome
Will determine the detailed clinical characterization including timing, severity, and phenotype of immune related adverse events (irAEs) in chronic survivors with melanoma from initiation of adjuvant checkpoint inhibitor (CPI) therapy through 24 months of follow-up. The primary end point will be at 12 months, but patients will be followed for up to 24 months. Will estimate the incidence rates of any de novo grade 2 or higher irAEs at 12 months post treatment initiation along with 95% confidence
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BEHAVIORAL Assessment
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2019-12-05 |
| Est. Completion | 2027-02-02 |
What the registry record for NCT04990726 still lists
NCT04990726 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 237-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (47% lower).
The record links to 8 conditions, with Clinical Stage III Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04990726 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04990726 about?
NCT04990726 is a clinical study titled "Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors". This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy,...
What is the current status of trial NCT04990726?
This trial is currently active not recruiting. The enrollment target is 126 participants. The study started on 2019-12-05. Estimated completion is 2027-02-02.
What conditions does trial NCT04990726 study?
This clinical trial studies the following conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, Melanoma Stage IV, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT04990726?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT04990726?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04990726 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04990726's enrollment target sits among peer trials
126 10th of 23 higher than 14 of 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III 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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