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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07215988
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-interventional study

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Cohort 1: Merkel cell carcinoma
    Patients complete a survey and have their medical records reviewed on study.
  • Arm: Cohort 2: Mucosal melanoma
    Patients complete a survey and have their medical records reviewed on study.
  • Arm: Cohort 3: Basal cell carcinoma
    Patients complete a survey and have their medical records reviewed on study.
  • Arm: Cohort 4: Rare cutaneous cancers
    Patients complete a survey and have their medical records reviewed on study.

Primary Outcome Measure

Time spent obtaining approval and drugs [ Time Frame: Up to study completion, up to 17 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Claire F. Verschraegen, MD
[email protected]
614-366-5068
Claire F. Verschraegen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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