5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results (INTEGRATE)
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| ClinicalTrials.gov Identifier: NCT02355574 |
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Recruitment Status :
Terminated
(Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.)
First Posted : February 4, 2015
Last Update Posted : October 8, 2021
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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 |
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| Cutaneous Melanoma |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 301 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| 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 : | June 2014 |
| Actual Primary Completion Date : | February 2021 |
| Actual Study Completion Date : | July 2021 |
- 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.
- 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
- Early referral to medical oncologist for high risk patients. [ Time Frame: Upon Receipt DecisionDx-Melanoma results ]referral
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355574
| United States, Georgia | |
| Northside Hospital | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Missouri | |
| Saint Louis University | |
| Saint Louis, Missouri, United States, 63103 | |
| Principal Investigator: | Robert Cook, PhD | Castle Biosciences Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Castle Biosciences Incorporated |
| ClinicalTrials.gov Identifier: | NCT02355574 |
| Other Study ID Numbers: |
INTEGRATE_1_Protocol |
| First Posted: | February 4, 2015 Key Record Dates |
| Last Update Posted: | October 8, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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melanoma cutaneous melanoma DecisionDx-Melanoma |
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |