MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)

  • End date
    Apr 23, 2028
  • participants needed
  • sponsor
Updated on 4 October 2022
melanoma skin
malignant melanoma of skin


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 Melanoma
Clinical Study IdentifierNCT04759781
Last Modified on4 October 2022


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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