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Brief Title: ctDNA for Early Detection of Recurrence in Melanoma
Official Title: The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma
Study ID: NCT06246227
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Detp. of Pastic and Reconstructive Surgery, Herlev Hospital, Herlev, , Denmark
Name: Lisbet R Hölmich, MD, DMSc, Clinical Professor
Affiliation: Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
Role: STUDY_DIRECTOR