RecruitingNCT07215988

Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

70 participants

Start Date

Feb 4, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking real-world outcomes for patients with rare skin cancers — including Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, and certain squamous cell carcinomas — who receive standard immunotherapy or targeted treatments before surgery. The goal is to understand how well these treatments work and how insurance covers them. **You may be eligible if...** - You are 18 or older with a biopsy-confirmed diagnosis of one of the eligible skin cancer types - Your cancer is resectable (can be surgically removed) or may become resectable after treatment - You are scheduled to receive standard immunotherapy or targeted therapy before surgery - Genomic (genetic) testing of your cancer has been attempted **You may NOT be eligible if...** - Your cancer has spread so extensively that complete surgical removal is not possible - You have had prior treatment (immunotherapy, chemotherapy, or radiation) for this cancer - You have any medical condition that your doctor considers a contraindication to immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-Interventional Study

Non-interventional study


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07215988


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