MelanomaNCT06246227
ctDNA for Early Detection of Recurrence in Melanoma
An observational study of Melanoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- Type of treatment
- Injection or infusion
- How many people
- 467 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 1 Jan 2028
- 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
- Adult, Older adult
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.
Who may be able to join
- Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV
Who cannot join
- Pregnancy
- Previous history of melanoma
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Detp. of Pastic and Reconstructive Surgery, Herlev Hospital
Herlev, 2730
About this study
Official title: The Value of Circulating Tumour DNA in Early Detection of Recurrence of 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.
Read the 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.
- Conditions
- Melanoma
- Keywords
- ctDNA, Melanoma, Recurrence, Detection, ddPCR, NGS
- Medical subject headings
- Melanoma, Recurrence
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 |
|---|---|---|
| High Risk Melanoma Patients | Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to end of 5-year follow-up
Secondary outcomes (2)
Time from detectable ctDNA to clinical og radiological suspicion of recurrence
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.
Measured: 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
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.
Measured: From enrollment to end of 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jul 2019
- Primary completion6 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 467 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, Clinical Professor, Study director, Dept. of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246227
- Sponsor's protocol ID
- H-18008586-S1
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2024
- Last updated
- 24 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma
- ClinicalTrials.gov ID
- NCT06246227
- Acronym / sponsor ID
- H-18008586-S1
- Conditions
- Melanoma
- Keywords
- ctDNA, Melanoma, Recurrence, Detection, ddPCR, NGS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 467 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
- 1 Jul 2019 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Feb 2024 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Melanoma Patients | – | –Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV
Key exclusion criteria (2 listed)
- Pregnancy
- Previous history of melanoma
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
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.
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.
2 secondary outcomes
Time from detectable ctDNA to clinical og radiological suspicion of recurrence
Time frame: 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
Time frame: From enrollment to end of 5-year follow-up
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 24 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, Clinical 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, 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 1 inclusion and 2 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 24 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?
Sensitivity of ctDNA for detection of metastatic disease (time frame: From enrollment to end of 5-year follow-up). The study lists 2 primary outcomes in all. 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 24 Apr 2026.