NCT04117373

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

October 3, 2019

Last Update Submit

March 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary cost

    How does interpolation flap procedure cost differ across settings

    Claims from 2001-2016 will be analyzed

Secondary Outcomes (1)

  • Predictors of inpatient vs. outpatient procedure

    Claims from 2001-2016 will be analzyed

Study Arms (1)

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.

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeremy Etzkorn, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations