Actively Recruiting
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-01
70
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Pathology report confirming diagnosis of Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, or squamous cell carcinoma
- Stage II, III, or IV resectable or unresectable skin cancer amenable to surgery if response to neoadjuvant therapy occurs
- Genomic testing of the cancer attempted
- Description of planned surgical resection by surgeon
- Planned treatment with immunotherapy or standard of care neoadjuvant therapy for 12 weeks prior to surgery
You will not qualify if you...
- Metastatic disease not amenable to complete resection
- Prior immunotherapy, chemotherapy, or radiation therapy for current skin cancer
- Any significant medical condition that contraindicates immunotherapy
- Pregnant, breastfeeding, or planning to conceive or father children during the study and up to 120 days after last treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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