Actively Recruiting
Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
Led by University of California, San Francisco · Updated on 2025-11-10
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how immune checkpoint inhibitors (ICIs), a type of treatment for stages IIB to IV cutaneous melanoma, affect patients' symptom experiences over time. This observational study aims to understand different symptom patterns and identify factors like demographics, clinical status, environment, and molecular markers that might be linked to worse symptoms. Filling this knowledge gap will help improve symptom management and guide treatment decisions for patients with this common skin cancer. Participants are adults diagnosed with stage IIB to IV cutaneous melanoma who will be receiving immune checkpoint inhibitor therapy as part of their usual care. The study involves reviewing medical charts from the start of their treatment for up to four cycles. Participants may also complete health-related quality of life questionnaires and provide blood samples during regular clinic visits to support research on symptom experiences. Throughout the study, participants will be monitored for the frequency and types of symptoms they report up to five months after treatment begins. The research team will analyze symptom profiles and explore risk factors for worse symptom experiences. Blood samples and questionnaires collected at clinic visits will help track changes in symptoms and quality of life. The total participation duration varies with ongoing data collection during the initial treatment phase.
CONDITIONS
Brief Title
Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Able to speak and read English
- Diagnosed with stage IIB, III, or IV cutaneous melanoma
- Scheduled to receive at least one immune checkpoint inhibitor at University of California San Francisco medical centers
- Participants on targeted therapies like BRAF or MEK inhibitors are also eligible
- Provide written informed consent to participate
You will not qualify if you...
- Unable to complete study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 months
Participants who receive immune checkpoint inhibitor therapy as part of their usual care are observed through medical chart reviews, symptom questionnaires, and blood sample collections during regular clinic visits.
Regular clinic visits for up to 5 months
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
E
Erin Hubbard, MPH
C
Carolyn Harris, PhD, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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