Melanoma (Skin Cancer)NCT07531121
ctDNA for Risk Stratification in Melanoma
An observational study of Melanoma (Skin Cancer), run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
This study examines circulating tumor DNA (ctDNA) as a biomarker in patients with primary melanoma, prior to surgical excision. The hypothesis is that ctDNA may be detectable in pre-operative blood samples from patients with high-risk primary melanoma, potentially providing a baseline measurement for future disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer)
- How many people
- 296 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Sep 2021to 3 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with suspicion of primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, in the inclusion period.
Who may be able to join
- Age 18 years or older
- Clinical suspicion of primary cutaneous melanoma
- Presenting at the Department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
- Able to provide written informed consent
Who cannot join
- Age less than 18 years
- Pregnancy
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
Herlev, 2730
About this study
Official title: The Value of Circulating Tumour DNA in Risk Stratification in Melanoma
This study examines circulating tumor DNA (ctDNA) as a biomarker in patients with primary melanoma, prior to surgical excision. The hypothesis is that ctDNA may be detectable in pre-operative blood samples from patients with high-risk primary melanoma, potentially providing a baseline measurement for future disease monitoring.
Read the detailed description
This prospective, single-institution study recruits patients presenting with suspected primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University. Patients with invasive melanoma of stage T3a or higher, or with sentinel node metastasis (N1a or higher), and no distant metastasis (M0) will be selected for final analysis.
Pre-operative blood samples are collected prior to surgical excision. Plasma is harvested and stored. Tumor tissue from excised melanomas is analyzed using next-generation sequencing (NGS, Oncomine Tumor Mutational Load panel) to determine the mutational profile. For patients with targetable mutations, corresponding plasma samples are analyzed for ctDNA using either digital droplet PCR (ddPCR) or plasma NGS depending on the local availability of validated mutation-specific assays.
Enrollment will take place from September 2021 to December 2022, with laboratory analyses expected to be completed in 2025 and final analysis completed by May 2026. This study shares the ethical approval (H-18008586) and biobank infrastructure with a parallel study investigating ctDNA for detection of melanoma recurrence (NCT06246227).
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- ctdna, melanoma, stratification, ddpcr, ngs, biomarker
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Melanoma Patients | Patients presenting with suspected primary melanoma prior to surgical excision. Patients that are shown to have invasive melanoma of stage T3a or higher, OR sentinel node metastasis N1a or higher OR distant metastasis M1 or higher, and a targetable tumor mutation in tissue sample are selected for ctDNA analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS
A venous blood sample is drawn before surgical excision of the primary melanoma. Plasma is isolated and analyzed for the presence of the same cancer-specific DNA mutation previously identified in the patient's tumor tissue. Two methods are used depending on mutation type: digital droplet PCR (ddPCR, Bio-Rad QX200) for BRAF V600E mutations, or targeted next-generation sequencing (Oncomine Tumor Mutational Load panel, Ion Torrent S5) for other mutations.
A sample is classified as "detected" if at least one confirmed mutant DNA copy is identified by ddPCR, or if the tumor-specific variant is present above the assay detection threshold by NGS. The outcome is reported as the number of participants with detected ctDNA out of the total number of participants analyzed.
Measured: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation
Secondary outcomes (1)
Number of Participants With Detectable ctDNA by Tumor Stage as Assessed by ddPCR or Targeted NGS
The number of participants with detectable ctDNA is reported separately for each AJCC 8th edition stage group (IIB, IIC, IIIA, IIIB, IIIC) represented in the study patient cohort. This exploratory outcome evaluates whether more advanced tumor stage is associated with a higher likelihood of ctDNA detection.
Stage is determined from pathological T-classification (based on Breslow thickness and ulceration) and sentinel node status according to AJCC Cancer Staging Manual, 8th edition.
Measured: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Sep 2021
- Primary completion20 May 2025
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Danish Cancer Research Foundation, DCCC ctDNA Research Center, CAG in Cancer immunotherapy
- Responsible party
- Principal investigator, Magnus Petur Bjarnason Obinah, Herlev and Gentofte Hospital
- Investigators
- Lisbet R Hölmich, MD, DMSc, Professor, Study director, Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531121
- Sponsor's protocol ID
- H-18008586-S2
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Circulating Tumour DNA in Risk Stratification in Melanoma
- ClinicalTrials.gov ID
- NCT07531121
- Acronym / sponsor ID
- H-18008586-S2
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- ctdna, melanoma, stratification, ddpcr, ngs, biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Danish Cancer Research Foundation, DCCC ctDNA Research Center, CAG in Cancer immunotherapy
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines circulating tumor DNA (ctDNA) as a biomarker in patients with primary melanoma, prior to surgical excision. The hypothesis is that ctDNA may be detectable in pre-operative blood samples from patients with high-risk primary melanoma, potentially providing a baseline measurement for future disease monitoring.
Detailed description
This prospective, single-institution study recruits patients presenting with suspected primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University. Patients with invasive melanoma of stage T3a or higher, or with sentinel node metastasis (N1a or higher), and no distant metastasis (M0) will be selected for final analysis.
Pre-operative blood samples are collected prior to surgical excision. Plasma is harvested and stored. Tumor tissue from excised melanomas is analyzed using next-generation sequencing (NGS, Oncomine Tumor Mutational Load panel) to determine the mutational profile. For patients with targetable mutations, corresponding plasma samples are analyzed for ctDNA using either digital droplet PCR (ddPCR) or plasma NGS depending on the local availability of validated mutation-specific assays.
Enrollment will take place from September 2021 to December 2022, with laboratory analyses expected to be completed in 2025 and final analysis completed by May 2026. This study shares the ethical approval (H-18008586) and biobank infrastructure with a parallel study investigating ctDNA for detection of melanoma recurrence (NCT06246227).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Melanoma Patients | – | –Patients presenting with suspected primary melanoma prior to surgical excision. Patients that are shown to have invasive melanoma of stage T3a or higher, OR sentinel node metastasis N1a or higher OR distant metastasis M1 or higher, and a targetable tumor mutation in tissue sample are selected for ctDNA analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with suspicion of primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, in the inclusion period.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Clinical suspicion of primary cutaneous melanoma
- Presenting at the Department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
- Able to provide written informed consent
Key exclusion criteria (3 listed)
- Age less than 18 years
- Pregnancy
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS
Time frame: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation
A venous blood sample is drawn before surgical excision of the primary melanoma. Plasma is isolated and analyzed for the presence of the same cancer-specific DNA mutation previously identified in the patient's tumor tissue. Two methods are used depending on mutation type: digital droplet PCR (ddPCR, Bio-Rad QX200) for BRAF V600E mutations, or targeted next-generation sequencing (Oncomine Tumor Mutational Load panel, Ion Torrent S5) for other mutations. A sample is classified as "detected" if at least one confirmed mutant DNA copy is identified by ddPCR, or if the tumor-specific variant is present above the assay detection threshold by NGS. The outcome is reported as the number of participants with detected ctDNA out of the total number of participants analyzed.
1 secondary outcome
Number of Participants With Detectable ctDNA by Tumor Stage as Assessed by ddPCR or Targeted NGS
Time frame: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisbet R Hölmich, MD, DMSc, Professor study director
Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin Cancer), run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS (time frame: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.