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

Part of paid clinical trials in Davis, California.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06673095
Status
Recruiting
Apply to this trial

Conditions

  • Clinical Stage IA Cutaneous Melanoma AJCC v8
  • Clinical Stage IB Cutaneous Melanoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Excision — PROCEDURE
    Undergo narrow margin excision
  • Excision — PROCEDURE
    Undergo wide margin excision
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Dec 11, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Local recurrence rate [ Time Frame: From randomization to end of year 3 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95817
Daniel Eisen, MD
[email protected]
Daniel Eisen, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536
Leah Winer, M.D.
[email protected]
University of MichiganAnn ArborMichigan48109
Tiffany Libtow
[email protected]
Michael Davis, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Bryan Carroll, MD
[email protected]
Bryan Carroll, MD (PRINCIPAL_INVESTIGATOR)
OHSU Knight Cancer InstitutePortlandOregon97239
Paige Smith
[email protected]
503-418-4268
Noah Hornick, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Davis, CA

By research site
University of California, Davis· Davis, CAUniversity of Kentucky/Markey Cancer Center· Lexington, KYUniversity of Michigan· Ann Arbor, MIUniversity Hospitals Cleveland Medical Center· Cleveland, OHOHSU Knight Cancer Institute· Portland, OR

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