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

NCT07215988 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8
  • Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
  • Locally Advanced Basal Cell Carcinoma
  • Locally Advanced Malignant Skin Neoplasm
  • Locally Advanced Merkel Cell Carcinoma
  • Locally Advanced Mucosal Melanoma
  • Locally Advanced Squamous Cell Carcinoma

Interventions

OTHER

Non-Interventional Study

Non-interventional study

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Claire F Verschraegen, MD · Ohio State University Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215988 on ClinicalTrials.gov