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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 October 2021 |
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Main ID: |
NCT02355574 |
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Date of registration:
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18/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results
INTEGRATE |
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Scientific title:
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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 |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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301 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02355574 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Cook, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Castle Biosciences Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cutaneous Melanoma
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Primary Outcome(s)
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Adjusted surveillance regimen
[Time Frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter]
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Secondary Outcome(s)
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Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
[Time Frame: Upon receipt DecisionDx-Melanoma results]
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Secondary ID(s)
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INTEGRATE_1_Protocol
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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