MelanomaMERLIN_001NCT04759781
MElanoma Research Lymph Node Prediction Implementation National_001
An observational study of Melanoma, run by SkylineDx at 9 sites in United States.
Trial summary
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 1,820 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Aug 2021to Jun 2029
- 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: Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.
Who may be able to join
- Newly diagnosed patients with invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation.
- Male or female, age ≥18 years.
Who cannot join
- Full primary melanoma pathology report unavailable.
- Documented clinically apparent nodal metastases at diagnosis.
- Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
- Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
- Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
- Previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
- Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
Duke University
Durham, North Carolina, 27705
University of Kentucky
Lexington, Kentucky, 40506
University of Louisville
Louisville, Kentucky, 40292
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Prospective Registry Study of a Primary Melanoma Gene-signature to Predict Sentinel Node (SN) Status and Determine Its Prognostic Value for More Accurate Staging of SN-negative Melanoma Patients.
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
- Conditions
- Melanoma
- Keywords
- prospective study, gene expression, melanoma, Merlin, assay
- Medical subject headings
- Melanoma, Neurofibromatosis 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value (NPV)
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Measured: 2 years after inclusion
Positive Predictive Value (PPV)
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Measured: 2 years after inclusion
Sensitivity and Specificity.
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Measured: 2 years after inclusion
Secondary outcomes (3)
3-5 year Recurrence-Free Survival (RFS)
Time between the date of sentinel lymph node biopsy procedure and the date of first melanoma recurrence (loco-regional or distant metastasis) or date of death (whatever the cause), whichever occurs first.
Measured: 3-5 years after patient inclusion
3-5 year Distant Metastasis-Free Survival (DMFS)
Time between the date of sentinel lymph node biopsy procedure and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first.
Measured: 3-5 years after patient inclusion
3-5 year Overall Survival (OS)
Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).
Measured: 3-5 years after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start25 Aug 2021
- Primary completion28 Jun 2024
- Study completionJun 2029 (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
- 1,820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkylineDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vernon K. Sondak, MD, Principal investigator, Moffitt Cancer CenterTina J. Hieken, MD, Principal investigator, Mayo ClinicMichael E. Egger, MD, MPH, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759781
- Sponsor's protocol ID
- MERLIN_001
- Acronym
- MERLIN_001
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2021
- Last updated
- 23 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study of a Primary Melanoma Gene-signature to Predict Sentinel Node (SN) Status and Determine Its Prognostic Value for More Accurate Staging of SN-negative Melanoma Patients.
- ClinicalTrials.gov ID
- NCT04759781
- Acronym / sponsor ID
- MERLIN_001 / MERLIN_001
- Conditions
- Melanoma
- Keywords
- prospective study, gene expression, melanoma, Merlin, assay
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,820 participants (estimated)
- Lead sponsor
- SkylineDxIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Feb 2021 (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.
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.
Key inclusion criteria (2 listed)
- Newly diagnosed patients with invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation.
- Male or female, age ≥18 years.
Key exclusion criteria (7 listed)
- Full primary melanoma pathology report unavailable.
- Documented clinically apparent nodal metastases at diagnosis.
- Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
- Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
- Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
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
Negative Predictive Value (NPV)
Time frame: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Positive Predictive Value (PPV)
Time frame: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Sensitivity and Specificity.
Time frame: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
3 secondary outcomes
3-5 year Recurrence-Free Survival (RFS)
Time frame: 3-5 years after patient inclusion
3-5 year Distant Metastasis-Free Survival (DMFS)
Time frame: 3-5 years after patient inclusion
3-5 year Overall Survival (OS)
Time frame: 3-5 years after patient inclusion
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 23 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.
Vernon K. Sondak, MD principal investigator
Moffitt Cancer Center
Tina J. Hieken, MD principal investigator
Mayo Clinic
Michael E. Egger, MD, MPH principal investigator
University of Louisville
9 sites 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 SkylineDx at 9 sites in United States.
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 2 inclusion and 7 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 23 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 9 sites in United States. 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?
Negative Predictive Value (NPV) (time frame: 2 years after inclusion). The study lists 3 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 23 Apr 2026.