NCT06246227

ctDNA for Early Detection of Recurrence in Melanoma

The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 467 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Melanoma

Timeline

• Start date: 2019-07-01
• Primary completion: 2027-10-06
• Completion: 2028-01-01
• First posted: 2024-02-07
• Last updated: 2024-03-12

Locations

1 site across 1 country: Denmark