Status:
ACTIVE_NOT_RECRUITING
MElanoma Research Lymph Node Prediction Implementation National_001
Lead Sponsor:
SkylineDx
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
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 mel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
1820 Patients enrolled
Trial Details
Trial ID
NCT04759781
Start Date
August 25 2021
End Date
June 1 2029
Last Update
July 8 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
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