NCT04759781: MERLIN_001

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.

Active, enrolled Last updated 22 April 2026

What this trial tests

trial in Melanoma in 1,820 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 August 2021

Primary endpoint
28 June 2024

1 June 2029

Quick facts

Lead sponsor	SkylineDx
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,820
Start date	25 August 2021
Primary completion	28 June 2024
Estimated completion	1 June 2029
Sites	9 locations across United States

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

SkylineDx

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Society of Surgical Oncology Consensus Statement: Assessing the Evidence for and Utility of Gene Expression Profiling of Primary Cutaneous Melanoma.
   Bartlett EK, O'Donoghue C, Boland G, Bowles T, et al · · 2025 · cited 12× · PMID 39470890 · DOI 10.1245/s10434-024-16379-2
2. Role of Sentinel Lymph Node Biopsy for Skin Cancer Based on Clinical Studies.
   Ishizuki S, Nakamura Y. · · 2023 · cited 5× · PMID 37444401 · DOI 10.3390/cancers15133291
3. Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study.
   Hieken TJ, Sadurní MB, Quattrocchi E, Kobic A, et al · · 2022 · cited 4× · PMID 35100440 · DOI 10.1111/ijd.16056
4. Adjuvant Therapy for High-Risk Stage II Melanoma: Current Paradigms in Management and Future Directions.
   Vargas GM, Farooq MS, Karakousis GC. · · 2024 · cited 3× · PMID 39123418 · DOI 10.3390/cancers16152690
5. ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Adaptive Narrow Excision Versus Wide Excision for Adults with AJCC Stage I Cutaneous Melanoma.
   Bichakjian CK, Swetter SM, Carroll BT, Vidal NY, et al · · 2025 · cited 1× · PMID 40921901 · DOI 10.1245/s10434-025-18282-w
6. Independent Dutch Validation Study of CP-GEP (Merlin Assay) for the Prediction of Nodal Metastasis and Long-Term Outcome in Patients with Primary Cutaneous Melanoma.
   Zijlker LP, Verwer Z, van der Wiel BA, Kuijpers AMJ, et al · · 2026 · PMID 41413281 · DOI 10.1245/s10434-025-18928-9