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NCT Number: NCT06246227

ctDNA for Early Detection of Recurrence in Melanoma

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Melanoma Disease Attributes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Detp. of Pastic and Reconstructive Surgery, Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Previous history of melanoma

Treatment and study plan

Primary outcomes

  1. Sensitivity of ctDNA for detection of metastatic disease

    Time frame: 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.

  2. Specificity of ctDNA for detection of metastatic disease

    Time frame: 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 outcomes

  1. Time from detectable ctDNA to clinical og radiological suspicion of recurrence

    Time frame: 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.

  2. Associations between ctDNA detection and quantification, and other biomarkers, including LDH, WBC differential, and HS-CRP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • CAG in Cancer immunotherapy
  • DCCC ctDNA Research Center
  • Danish Cancer Research Foundation
  • Danish Cancer Society

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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