Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759781
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
SkylineDx

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Melanoma

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2130 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 : August 25, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 3-5 year Recurrence-Free Survival (RFS) [ Time Frame: 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.

  2. 3-5 year Distant Metastasis-Free Survival (DMFS) [ Time Frame: 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. 3-5 year Overall Survival (OS) [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759781


Contacts
Layout table for location contacts
Contact: Dennie Tempel, PhD +31107200326 D.Tempel@skylinedx.com
Contact: Ashley van der Spek, MSc +31107200326 a.vanderspek@skylinedx.com

Locations
Layout table for location information
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Vernon K. Sondak, MD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Michael C. Lowe, MD/MA         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Erin E. Burke, MD         
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Michael E. Egger, MD/MPH         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Christina V. Angeles, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tina J. Hieken, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Edmund K. Bartlett, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: John R. Hyngstrom, MD         
Sponsors and Collaborators
SkylineDx
Investigators
Layout table for investigator information
Principal Investigator: Vernon K. Sondak, MD Moffitt Cancer Center
Principal Investigator: Tina J. Hieken, MD Mayo Clinic
Principal Investigator: Michael E. Egger, MD, MPH University of Louisville
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SkylineDx
ClinicalTrials.gov Identifier: NCT04759781    
Other Study ID Numbers: MERLIN_001
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SkylineDx:
prospective study
gene expression
melanoma
Merlin
assay
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas