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

StatusSuspended
PhaseNot applicable
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Pending coordinating center transition Show 4 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Site details revised at 5 of 5 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 1 → 5 locationsv5
  3. Eligibility criteria revisedv4
  4. Eligibility criteria shortened, about 39 words
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 13 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 20, 2024 to Dec 11, 2024
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06673095
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Conditions
(from sponsor)		 Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov