Cutaneous MelanomaINTEGRATENCT02355574
5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results
An observational study of Cutaneous Melanoma, run by Castle Biosciences Incorporated at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cutaneous Melanoma
- How many people
- 301 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to Jul 2021
- How long will I take part?
- 5 Years
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.
Who may be able to join
- 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
Who cannot join
- Less than 16 Years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Louisville
Louisville, Kentucky, 40202
Saint Louis University
St Louis, Missouri, 63103
About this study
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
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.
- Conditions
- Cutaneous Melanoma
- Keywords
- melanoma, cutaneous melanoma, DecisionDx-Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted surveillance regimen
- Relaxed surveillance for the low risk group;
- Increased vigilance for early detection in the high risk group.
Measured: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
Secondary outcomes (1)
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
referral to SLNB in HR melanoma
Measured: Upon receipt DecisionDx-Melanoma results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionFeb 2021
- Study completionJul 2021
Why it stopped: Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Castle Biosciences Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cook, PhD, Principal investigator, Castle Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355574
- Sponsor's protocol ID
- INTEGRATE_1_Protocol
- Acronym
- INTEGRATE
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Whitman ED, Koshenkov VP, Gastman BR, Lewis D, Hsueh EC, Pak H, Trezona TP, Davidson RS, McPhee M, Guenther JM, Toomey P, Smith FO, Beitsch PD, Lewis JM, Ward A, Young SE, Shah PK, Quick AP, Martin BJ, Zolochevska O, Covington KR, Monzon FA, Goldberg MS, Cook RW, Fleming MD, Hyams DM, Vetto JT. Integrating 31-Gene Expression Profiling With Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction. JCO Precis Oncol. 2021 Sep 13;5:PO.21.00162. doi: 10.1200/PO.21.00162. eCollection 2021.
PubMed 34568719Hsueh EC, DeBloom JR, Lee JH, Sussman JJ, Covington KR, Caruso HG, Quick AP, Cook RW, Slingluff CL Jr, McMasters KM. Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for Cutaneous Melanoma. JCO Precis Oncol. 2021 Apr 6;5:PO.20.00119. doi: 10.1200/PO.20.00119. eCollection 2021.
PubMed 34036233
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02355574
- Acronym / sponsor ID
- INTEGRATE / INTEGRATE_1_Protocol
- Conditions
- Cutaneous Melanoma
- Keywords
- melanoma, cutaneous melanoma, DecisionDx-Melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Castle Biosciences IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 4 Feb 2015 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 16 Years of age
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
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.
1 secondary outcome
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
Time frame: Upon receipt DecisionDx-Melanoma results
Results and safety
The study was stopped early (reason given: Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 34568719Whitman ED, Koshenkov VP, Gastman BR, Lewis D, Hsueh EC, Pak H, Trezona TP, Davidson RS, McPhee M, Guenther JM, Toomey P, Smith FO, Beitsch PD, Lewis JM, Ward A, Young SE, Shah PK, Quick AP, Martin BJ, Zolochevska O, Covington KR, Monzon FA, Goldberg MS, Cook RW, Fleming MD, Hyams DM, Vetto JT. Integrating 31-Gene Expression Profiling With Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction. JCO Precis Oncol. 2021 Sep 13;5:PO.21.00162. doi: 10.1200/PO.21.00162. eCollection 2021.
- Derived from this study: PubMed 34036233Hsueh EC, DeBloom JR, Lee JH, Sussman JJ, Covington KR, Caruso HG, Quick AP, Cook RW, Slingluff CL Jr, McMasters KM. Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for Cutaneous Melanoma. JCO Precis Oncol. 2021 Apr 6;5:PO.20.00119. doi: 10.1200/PO.20.00119. eCollection 2021.
- 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.
Robert Cook, PhD principal investigator
Castle Biosciences Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma, run by Castle Biosciences Incorporated at 3 sites 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 3 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: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 stopped early (reason given: Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.). Results are not available in the source record.
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?
Adjusted surveillance regimen (time frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355574, which also lists 2 linked publications.
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 8 Oct 2021.