ctDNA for Early Detection of Recurrence in Melanoma

Active, not recruiting

• Conditions: Melanoma

• Registration Number: NCT06246227
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2027-10-06
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

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

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Exclusion Criteria

• Pregnancy
• Previous history of melanoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of ctDNA for detection of metastatic disease	From enrollment to end of 5-year follow-up	By analyzing blood samples of patients diagnosed with recurrence, we will establish the ability of ctDNA to detect known recurrence, and therefore be able to establish the sensitivity of the method.
Specificity of ctDNA for detection of metastatic disease	From enrollment to end of 5-year follow-up	By assuming no ctDNA in healthy individuals and analyzing WBC from buffy-coat to correct for wild-type mutated DNA due to CHIP, we will be able to establish the specificity of the method.

Secondary Outcome Measures

Name	Time	Method
Time from detectable ctDNA to clinical og radiological suspicion of recurrence	From enrollment to end of 5-year follow-up	We will start by analyzing the closest sample to the original suspicion of recurrence. In the event of ctDNA detection, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected. This will allow us to establish a temporal relationship between the ability of ctDNA to detect recurrence and current surveillance methods.
Associations between ctDNA detection and quantification, and other biomarkers, including LDH, WBC differential, and HS-CRP	From enrollment to end of 5-year follow-up	By measuring LDH, WBC Diff. and HS-CRP at every sampling, we will be able to establish the correlation between these currently accepted biomarkers for melanoma-specific survival and ctDNA measurements.

Trial Locations

Locations (1)

Detp. of Pastic and Reconstructive Surgery, Herlev Hospital; 🇩🇰 Herlev, Denmark