Trials / Recruiting

RecruitingNCT07215988

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 70 (estimated)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess in real-life clinical practice, the timing, cost, and surgical outcomes of patients who have resectable various skin cancers that are locally advanced or have a high risk of recurrence. OUTLINE: This is an observational study. Patients complete a survey and have their medical records reviewed on study.

Conditions

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

Start date: 2026-02-04
Primary completion: 2027-12-31
Completion: 2027-12-31
First posted: 2025-10-14
Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07215988. Inclusion in this directory is not an endorsement.