MElanoma Research Lymph Node Prediction Implementation National_001

Active, not recruiting

• Conditions: Melanoma

• Registration Number: NCT04759781
• Lead Sponsor: SkylineDx

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Study Start: 2021-08-25
• Primary Completion: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1820

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative Predictive Value (NPV)	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)	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.	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.

Secondary Outcome Measures

Name	Time	Method
3-5 year Recurrence-Free Survival (RFS)	3-5 years after patient inclusion	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 year Distant Metastasis-Free Survival (DMFS)	3-5 years after patient inclusion	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 year Overall Survival (OS)	3-5 years after patient inclusion	Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).

Trial Locations

Locations (9)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States