MElanoma Research Lymph Node Prediction Implementation National_001

Melanoma Clinical Trial

— MERLIN_001  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759781
• Other study ID #: MERLIN_001
• Status: Recruiting
• Start date: August 25, 2021
• Est. completion date: August 2028

Study information

• Verified date: November 2023
• Source: SkylineDx
• Contact: Dennie Tempel, PhD
• Phone: +31107200326
• Email: D.Tempel[@]skylinedx.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2340
• Est. completion date: August 2028
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Duke University	Durham	North Carolina
United States	University of Kentucky	Lexington	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SkylineDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years after inclusion
Primary	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.	2 years after inclusion
Primary	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.	2 years after inclusion
Secondary	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.	3-5 years after patient inclusion
Secondary	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.	3-5 years after patient inclusion
Secondary	3-5 year Overall Survival (OS)	Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).	3-5 years after patient inclusion