MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 21-000516
NCT ID: NCT04759781
Sponsor Protocol Number: MERLIN_001
About this study
This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Newly diagnosed (biopsy within 120 days of study enrollment) invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines).
- pT1b-pT3 (Breslow thickness ≥ 0.8 mm to 4.0 mm) cN0M0; or
- pT1a (Breslow thickness < 0.8 mm) cN0M0 AND one or more of the following:
- Mitotic rate ≥ 2/mm2.
- Patient age at time of primary melanoma biopsy < 40 years old.
- Presence of lymphovascular invasion.
- Male or female, age ≥ 18 years.
- Elected to undergo sentinel lymph node biopsy per the treating physician’s recommendation.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Tina Hieken, M.D.
Open for enrollment
Breast Melanoma Oncology Research
Publications are currently not available