Skin CancerNCT04117373
Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database
An observational study of Skin Cancer and Mohs Micrographic Surgery, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Skin Cancer, Mohs Micrographic Surgery, Interpolated Flap Repair
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary cost
How does interpolation flap procedure cost differ across settings
Measured: Claims from 2001-2016 will be analyzed
Secondary outcomes (1)
Predictors of inpatient vs. outpatient procedure
How does medical specialty or geographical location predict where the procedure is performed
Measured: Claims from 2001-2016 will be analzyed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: The researchers were unable to answer the study question by utilizing the insurance claims database.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Etzkorn, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117373
- Sponsor's protocol ID
- 832285
- Status last verified
- Mar 2020
- First submitted
- 3 Oct 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Trends in Mohs Micrographic Surgery and Complex Reconstruction in the Optum Healthcare Population
- ClinicalTrials.gov ID
- NCT04117373
- Acronym / sponsor ID
- 832285
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The researchers were unable to answer the study question by utilizing the insurance claims database.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary cost
Time frame: Claims from 2001-2016 will be analyzed
How does interpolation flap procedure cost differ across settings
1 secondary outcome
Predictors of inpatient vs. outpatient procedure
Time frame: Claims from 2001-2016 will be analzyed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Etzkorn, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Mohs Micrographic Surgery, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary cost (time frame: Claims from 2001-2016 will be analyzed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.