Actively Recruiting
Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Led by OHSU Knight Cancer Institute · Updated on 2026-03-12
1000
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.
CONDITIONS
Official Title
Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or legally authorized representatives must provide written informed consent before any study procedures
- Age 18 years or older; all genders and ethnic groups are eligible
- Histologically confirmed primary cutaneous melanoma, including acral melanomas
- Clinical stage IA melanoma with Breslow thickness greater than 0.5 mm plus at least one high-risk feature (mitotic rate ≥ 2/mm2, age 42 or younger, lymphovascular invasion, head/neck location) or clinical stage IB melanoma
- If melanoma depth is uncertain due to wide transection, re-biopsy is required to confirm Breslow depth
- Index melanoma must be classified as low risk on the Merlin Assay
- Surgery must be completed within 120 days of the original diagnostic biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky score ≥ 50%)
- Patients with prior or concurrent malignancies that do not interfere with safety or efficacy assessments are eligible
- Participants with a history of HIV infection are eligible
- Ability to speak, read, and write in English or Spanish
You will not qualify if you...
- Uncertain diagnosis of melanoma (e.g., severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
- Prior wide local excision at the melanoma site
- Pure desmoplastic melanoma (> 90% desmoplastic type); melanomas with less than 90% desmoplastic type may be included
- Mucosal and ocular melanomas
- Evidence of satellite, in-transit, regional, or distant metastatic melanoma by physical, clinical, radiographic, or pathologic evaluation
- Known or suspected regional or distant metastatic cancer
- Prior surgery to clear lymph nodes in the probable draining lymphatic field, including sentinel lymph node biopsy for the index melanoma
- Planned adjuvant radiotherapy to the primary melanoma site after excision
- Unwillingness or inability to comply with study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Wesley Yu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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