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

Sponsor
Castle Biosciences Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT02355574
Collaborator
(none)
301
Enrollment
3
Locations
85
Actual Duration (Months)
100.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    301 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Feb 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Adjusted surveillance regimen [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.

    Secondary Outcome Measures

    1. Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. [Upon receipt DecisionDx-Melanoma results]

      referral to SLNB in HR melanoma

    Other Outcome Measures

    1. Early referral to medical oncologist for high risk patients. [Upon Receipt DecisionDx-Melanoma results]

      referral

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northside Hospital Atlanta Georgia United States 30342
    2 University of Louisville Louisville Kentucky United States 40202
    3 Saint Louis University Saint Louis Missouri United States 63103

    Sponsors and Collaborators

    • Castle Biosciences Incorporated

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Castle Biosciences Incorporated
    ClinicalTrials.gov Identifier:
    NCT02355574
    Other Study ID Numbers:
    • INTEGRATE_1_Protocol
    First Posted:
    Feb 4, 2015
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Castle Biosciences Incorporated
    melanoma
    cutaneous melanoma
    DecisionDx-Melanoma
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Oct 8, 2021