Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
NCT ID: NCT07148245
Last Updated: 2025-11-10
Study Results
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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RECRUITING
300 participants
OBSERVATIONAL
2025-10-13
2027-06-30
Brief Summary
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Detailed Description
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1. Evaluate for changes over time in the patients' symptom experience,
2. Identify distinct symptom profiles over time.
3. Evaluate for demographic, clinical, environmental, and molecular risk factors associated with a worse profile.
OUTLINE:
Participants receiving ICI outside the scope of this study as part of usual care will have a chart review from the first cycle of non-investigational treatment for up to 4 cycles. Participants may complete symptom and health-related quality of life questionnaires during the course of the study, and blood samples will be obtained at regular clinic visits.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults treated with Immune Checkpoint Inhibitor Therapy
Adult participants diagnosed with stage IIB to IV cutaneous melanoma who will begin immune checkpoint therapy at University of California, San Francisco medical center locations.
Blood Sample
Blood samples will be collected
Health Related Quality of Life Questionnaires (HRQoL)
Participants may be given HRQoLs during the course of data collection
Medical Chart Review
Participants will undergo medical charts review during the course of data collection
Interventions
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Blood Sample
Blood samples will be collected
Health Related Quality of Life Questionnaires (HRQoL)
Participants may be given HRQoLs during the course of data collection
Medical Chart Review
Participants will undergo medical charts review during the course of data collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to speak and read English
* Diagnosed with stage IIB, III, or IV cutaneous melanoma
* Participants who are scheduled to receive \>=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.
* Provide written informed consent to participate in this study.
* Participants with stage IIB or higher cutaneous melanoma
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Carolyn Harris, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Erin Hubbard, MPH
Role: primary
Role: backup
Other Identifiers
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NCI-2025-05718
Identifier Type: REGISTRY
Identifier Source: secondary_id
25858
Identifier Type: -
Identifier Source: org_study_id