NCT06673095 · OHSU Knight Cancer Institute
Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
What this study 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 the usual treatment 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Davis, California
- Lexington, Kentucky
- Ann Arbor, Michigan
- Cleveland, Ohio
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations