ctDNA for Early Detection of Recurrence in Melanoma

NCT06246227 | Active Not Recruiting

• 1 other identifier: H-18008586-S1
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

ctDNA; Melanoma; Recurrence; Detection; ddPCR; NGS

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ctDNA for detection of metastatic disease

  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.

  From enrollment to end of 5-year follow-up

• Specificity of ctDNA for detection of metastatic disease

  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.

  From enrollment to end of 5-year follow-up

Secondary Outcomes (2)

• Time from detectable ctDNA to clinical og radiological suspicion of recurrence

  From enrollment to end of 5-year follow-up

• 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

Study Arms (1)

High Risk Melanoma Patients

Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Previous history of melanoma

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Danish Cancer Society: collaborator
• Danish Cancer Research Foundation: collaborator
• DCCC ctDNA Research Center: collaborator
• CAG in Cancer immunotherapy: collaborator

Study Sites (1)

Detp. of Pastic and Reconstructive Surgery, Herlev Hospital

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples will be analyzed for mutations using NGS Plasma harvested from collected blood samples, for later ddPCR

MeSH Terms

Conditions

Melanoma; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisbet R Hölmich, MD, DMSc, Clinical Professor

  Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Medical Doctor, PhD Student

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: July 1, 2019
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)