Clinical trial NCT06246227: ctDNA for Early Detection of Recurrence in Melanoma
Official title: The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Keywords: ctDNA
Melanoma
Recurrence
Detection
ddPCR
NGS
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Cancer Research Foundation
name: DCCC ctDNA Research Center
name: CAG in Cancer immunotherapy
First posted: 2024-02-07
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV

Exclusion Criteria:

* Pregnancy
* Previous history of melanoma

Primary outcomes:
measure: Sensitivity of ctDNA for detection of metastatic disease
timeFrame: From enrollment to end of 5-year follow-up
measure: Specificity of ctDNA for detection of metastatic disease
timeFrame: From enrollment to end of 5-year follow-up
Secondary outcomes:
measure: Time from detectable ctDNA to clinical og radiological suspicion of recurrence
timeFrame: From enrollment to end of 5-year follow-up
measure: Associations between ctDNA detection and quantification, and other biomarkers, including LDH, WBC differential, and HS-CRP
timeFrame: From enrollment to end of 5-year follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Detp. of Pastic and Reconstructive Surgery, Herlev Hospital
Study officials:
affiliation: Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
name: Lisbet R Hölmich, MD, DMSc, Clinical Professor
role: STUDY_DIRECTOR
References: