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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05718 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| 4R00CA286967 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Procedure | Blood samples will be collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of symptoms reported over time | Evaluations of symptoms over time will be assessed via calculating the occurrence rates and means and standard deviations for the severity and distress ratings for all 53 symptoms and determine the most common, severe, and distressing symptoms over time. | Up to 5 months |
| Number of distinct symptom profiles identified | Latent class analysis will be used to identify subgroups of patients with distinct symptom occurrence profiles separately at each time point. Only symptoms that occurred in ≥20% of patients will used in the latent class analysis. | Up to 5 months |
| Number of risk factors identified with worse symptom profile over time. | Associations among the latent symptom occurrence profiles in demographic, clinical, environmental, and molecular characteristics along with financial toxicity, quality of life, and cancer-related distress will be evaluated using parametric and non-parametric methods to identify risk factors associated with a worse symptom profile over time. | Up to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with stage IIB, III, or IV cutaneous melanoma who will receive ≥ 1 immune checkpoint inhibitor therapy as part of treatment for cutaneous melanoma.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Hubbard, MPH | Contact | (415) 502-7774 | Erin.Hubbard@ucsf.edu | |
| Carolyn Harris, PhD, RN | Contact | Carolyn.Harris@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Harris, PhD, RN | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
De-identified datasets may be shared with study collaborators during the course of the study.
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Blood samples will be obtained
| Health Related Quality of Life Questionnaires (HRQoL) | Other | Participants may be given HRQoLs during the course of data collection |
|
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| Medical Chart Review | Other | Participants will undergo medical charts review during the course of data collection |
|
|
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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