MERLIN_001: MElanoma Research Lymph Node Prediction Implementation National_001

Sponsor

SkylineDx (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04759781

Collaborator

(none)

2,340

Enrollment

Locations

83.2

Anticipated Duration (Months)

260

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

2340 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Aug 25, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Aug 1, 2028

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	Emory University School of Medicine	Atlanta	Georgia	United States	30322
3	University of Kentucky	Lexington	Kentucky	United States	40506
4	University of Louisville	Louisville	Kentucky	United States	40292
5	University of Michigan	Ann Arbor	Michigan	United States	48109
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Duke University	Durham	North Carolina	United States	27705
9	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112