5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results (INTEGRATE)

October 1, 2021 updated by: Castle Biosciences Incorporated

An Ongoing, 5-year Post Market Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile (GEP) Assay Results and the Impact on Patient Outcomes and Health Economics

The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of medical records from clinical visits with physician.

The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

301

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Missouri
      • Saint Louis, Missouri, United States, 63103
        • Saint Louis University

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.

Description

Inclusion Criteria:

  • Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  • Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  • 16 Years and older

Exclusion Criteria:

  • Less than 16 Years of age

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted surveillance regimen
Time Frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
  • Relaxed surveillance for the low risk group;
  • Increased vigilance for early detection in the high risk group.
upon receipt DecisionDX-Melanoma results received and every 6 months thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
Time Frame: Upon receipt DecisionDx-Melanoma results
referral to SLNB in HR melanoma
Upon receipt DecisionDx-Melanoma results

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early referral to medical oncologist for high risk patients.
Time Frame: Upon Receipt DecisionDx-Melanoma results
referral
Upon Receipt DecisionDx-Melanoma results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castle Biosciences Incorporated

Investigators

  • Principal Investigator: Robert Cook, PhD, Castle Biosciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2014

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTEGRATE_1_Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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