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NCT07215988 · ClinicalTrials.gov registry record
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
A clinical trial of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- 70
- Enrollment target
- 1
- Study location
NCT07215988: Recruiting study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
NCT07215988 is a study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 70 participants, above the 22-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (218% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215988, a study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Start and end times for obtaining approval for drugs will be based on date the initial request is submitted by the provider and the date the drugs are obtained. Confidence intervals will provide precision for estimating the mean time spent on obtaining approval and drugs and out-of-pocket expenses for patients.
Conditions Studied
Interventions
- OTHER Non-Interventional Study
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2026-01-25 |
| Est. Completion | 2027-12-31 |
What NCT07215988 shows while recruiting
NCT07215988 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 22-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (218% higher).
The record links to 8 conditions, with Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which Non-Interventional Study is the first listed.
NCT07215988 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07215988 about?
NCT07215988 is a clinical study titled "Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study". 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. "Neoadj...
What is the current status of trial NCT07215988?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2026-01-25. Estimated completion is 2027-12-31.
What conditions does trial NCT07215988 study?
This clinical trial studies the following conditions: 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 Merkel Cell Carcinoma, Locally Advanced Mucosal Melanoma.
What interventions are being tested in trial NCT07215988?
The interventions under investigation include: Non-Interventional Study (OTHER).
Who is sponsoring clinical trial NCT07215988?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215988 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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