- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117373
Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database
March 4, 2020 updated by: University of Pennsylvania
Characterizing Trends in Mohs Micrographic Surgery and Complex Reconstruction in the Optum Healthcare Population
Mohs micrographic surgery (MMS) followed by skin reconstruction has been widely accepted for treatment of many skin cancers.
To further characterize the trends in MMS and reconstruction for skin cancer, a retrospective analysis will be performed using the Optum© Clinformatics® DataMart de-identified commercial claims database from 2001-2016.
The findings may provide critical data for future prospective studies in skin cancer treatments.
Study Overview
Status
Withdrawn
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population was conveniently sampled from the compilation of de-identified claims in the Optum© Clinformatics® database using ICD9 and ICD10 codes specific for skin cancer and linking them to specific CPT codes for interpolated flap repair, a reconstructive skin surgery.
The investigator's population is composed of >7,000 patients across the United States who received a skin cancer diagnosis and this procedure between 2001 and 2016.
Description
Inclusion criteria:
- All patients in the Optum© Clinformatics® database who have an ICD9 or ICD10 code for skin cancer and a corresponding CPT code specific for interpolated flap reconstruction
Exclusion criteria:
- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1
Patients from the existing Optum insurance claimed database with a confirmed diagnosis of melanoma, basal cell carcinoma, or squamous cell carcinoma who have undergone skin cancer excision surgery followed by interpolated flap repair between the years 2001-2006.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary cost
Time Frame: Claims from 2001-2016 will be analyzed
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How does interpolation flap procedure cost differ across settings
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Claims from 2001-2016 will be analyzed
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors of inpatient vs. outpatient procedure
Time Frame: Claims from 2001-2016 will be analzyed
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How does medical specialty or geographical location predict where the procedure is performed
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Claims from 2001-2016 will be analzyed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 4, 2019
First Posted (Actual)
October 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 832285
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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