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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Contact Information
Primary
Wesley Yu, M.D.
yuwe@ohsu.edu
503-418-9386
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1000
Treatments
Experimental: Arm I (narrow margin excision)
Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
Active_comparator: Arm II (wide margin excision)
Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials