ICEMAN Trial: Narrow vs. Wide Excision for Melanoma

This study, called the ICEMAN trial, is comparing two surgical approaches for adults with early-stage invasive cutaneous melanoma (a type of skin cancer). You might be eligible if you are 18 or older and have been diagnosed with Clinical Stage IA or IB cutaneous melanoma. The trial is looking at whether removing the melanoma with a narrow margin (less surrounding healthy tissue) is as effective as the current standard, which uses a wider margin. Researchers hope narrow margin excision could reduce surgical complications and improve quality of life. The main goal is to see how many people have their melanoma return locally within three years.

Study design
This is an interventional study planning to enroll 1000 participants. Participants will be randomly assigned to receive either narrow margin excision or wide margin excision.
What's involved
You would undergo either a narrow or wide margin excision. You may also be asked to provide blood samples and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
The study will track local recurrence rates for three years after randomization, and other outcomes for up to five years.

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NCT06673095

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

Recruiting
NAAges 18+InterventionalTreatment
OHSU Knight Cancer Institute
~1,000 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Biospecimen CollectionExcisionSurvey Administration

At a glance

Recruiting sites
1 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local recurrence rate
Measured over From randomization to end of year 3
Clinical Stage IA Cutaneous Melanoma AJCC v8
Clinical Stage IB Cutaneous Melanoma AJCC v8
5 sites across 5 states
California1
Kentucky1
Michigan1
Ohio1
Oregon1
  • Noah Hornick, M.D. · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

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Eligibility criteria

Inclusion

Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included
Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible.
Participants must have one of the following:
American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease with Breslow thickness \> 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location)
AJCC 8th Ed Clinical Stage IB melanoma
If a melanoma is widely transected and the true Breslow depth is uncertain, then to be eligible for this trial, the melanoma must be re-biopsied to ascertain an accurate Breslow depth.
The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
Study intervention (surgery) must be completed within 120 days of the original diagnostic biopsy
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Participants with a history of HIV infection are eligible
Participants can speak, read and write in English or Spanish

Exclusion

Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
The patient has already undergone wide local excision at the site of the primary index lesion
The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma is defined as being \> 90% desmoplastic type. Melanomas with \< 90% desmoplastic type may be included in this trial
Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
Participants with known or suspected cancer with regional or distant metastasis are excluded from this clinical trial because this trial is aimed at evaluating the control of localized disease
The patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including a sentinel lymph node biopsy, of the index melanoma
Planned adjuvant radiotherapy to the primary melanoma site after excision
Participant is unwilling or unable to comply with study procedures
  • Local recurrence rateFrom randomization to end of year 3

    Defined as average rate at which cancer returns to same location as the original tumor.