Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
467 participants
OBSERVATIONAL
2019-07-01
2028-01-01
Brief Summary
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Detailed Description
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Enrolled patients will undergo regular blood sampling. Samples will be centrifuged and plasma will be harvested and stored. In cases of metastasis or recurrence, tumor tissue samples will be analyzed using NGS to determine their mutational profile. Plasma samples will be analyzed for ctDNA corresponding to identified mutations. If ctDNA is detected, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected.
Follow-up time after inclusion is five years or end of clinical-follow up, with an interim sample and data analysis scheduled for 2024 and final analysis scheduled for 2027-2028.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High Risk Melanoma Patients
Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous history of melanoma
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Danish Cancer Research Foundation
OTHER
DCCC ctDNA Research Center
UNKNOWN
CAG in Cancer immunotherapy
UNKNOWN
Herlev and Gentofte Hospital
OTHER
Responsible Party
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Magnus Petur Bjarnason Obinah
Resident Medical Doctor, PhD Student
Principal Investigators
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Lisbet R Hölmich, MD, DMSc, Clinical Professor
Role: STUDY_DIRECTOR
Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
Locations
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Detp. of Pastic and Reconstructive Surgery, Herlev Hospital
Herlev, , Denmark
Countries
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Other Identifiers
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H-18008586
Identifier Type: -
Identifier Source: org_study_id
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