University of California, San Francisco
The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.
Cutaneous Melanoma
Cutaneous Melanoma, Stage III
Cutaneous Melanoma by AJCC V7 Stage
Cutaneous Melanoma, Stage IV
Blood Sample
Health Related Quality of Life Questionnaires (HRQoL)
Medical Chart Review
PRIMARY OBJECTIVES: 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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 300 participants |
| Official Title : | Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy |
| Actual Study Start Date : | 2025-10-13 |
| Estimated Primary Completion Date : | 2027-06-30 |
| Estimated Study Completion Date : | 2027-06-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of California, San Francisco
San Francisco, California, United States, 94143