NCT07215988 Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
| NCT ID | NCT07215988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8 |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. "Neoadjuvant therapy" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an "off-label" approach for several types of skin cancers. "Off-label" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these "off-label" treatments could be delayed compared to label use, and "off-label" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.
Eligibility Criteria
Inclusion Criteria: * \* MERKEL CELL CARCINOMA * Signed informed consent * Pathology report confirming Merkel at the time of screening * Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149) * 2 cycles will be given prior to surgery (=12 weeks). * MUCOSAL MELANOMA * Signed informed consent * Pathology report confirming mucosal melanoma at the time of screening * Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy * ≥ 18 years of age * Genomics of the cancer attempted * Description of plann