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Trial Title:
ctDNA for Early Detection of Recurrence in Melanoma
NCT ID:
NCT06246227
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Recurrence
Conditions: Keywords:
ctDNA
Melanoma
Recurrence
Detection
ddPCR
NGS
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of
recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis
is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of
or earlier than current methods, leading to improved management and hopefully prognosis,
based on earlier detection.
Detailed description:
This prospective, single-institution study will recruit patients attending follow-up for
primary melanoma with high risk of recurrence, at the department of Plastic and
Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University.
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.
Criteria for eligibility:
Study pop:
All patients followed for high-risk of recurrence, at the department of Plastic and
Reconstructive Surgery, Herlev and Gentofte University Hospital, in the inclusion period.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV
Exclusion Criteria:
- Pregnancy
- Previous history of melanoma
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Detp. of Pastic and Reconstructive Surgery, Herlev Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Start date:
July 1, 2019
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Herlev and Gentofte Hospital
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Research Foundation
Agency class:
Other
Collaborator:
Agency:
DCCC ctDNA Research Center
Agency class:
Other
Collaborator:
Agency:
CAG in Cancer immunotherapy
Agency class:
Other
Source:
Herlev and Gentofte Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246227
