RecruitingNot ApplicableNCT06673095

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

ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas


Sponsor

OHSU Knight Cancer Institute

Enrollment

1,000 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called ICEMAN) is comparing two surgical approaches for people with early-stage invasive skin melanoma: a standard wide excision (removing a larger margin of skin around the tumor) versus a narrower excision (removing less surrounding skin). The goal is to find out whether taking a smaller margin is just as safe. **You may be eligible if...** - You are 18 or older with confirmed primary invasive skin melanoma - Your melanoma is clinical stage IA (with high-risk features) or stage IB according to current staging guidelines - Your melanoma's Breslow thickness is greater than 0.5 mm **You may NOT be eligible if...** - Your melanoma has spread to the lymph nodes or other organs - You have a rare type of melanoma (such as desmoplastic or uveal melanoma) that has different surgical guidelines - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREExcision

Undergo narrow margin excision

PROCEDUREExcision

Undergo wide margin excision

OTHERSurvey Administration

Ancillary studies


Locations(5)

University of California, Davis

Davis, California, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT06673095


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