RECRUITING

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

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Conditions

Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-11
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06673095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
  2. * Age ≥ 18 years. Both men and women and members of all races and ethnic groups will be included
  3. * Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible. Mucosal and ocular melanomas are excluded. Pure desmoplastic melanomas (\> 90% desmoplastic) are also excluded
  4. * Participants must have one of the following:
  5. * 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)
  6. * AJCC 8th Ed Clinical Stage IB melanoma
  7. * AJCC 8th Ed Clinical Stage IIA melanoma
  8. * 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. If a melanoma is narrowly transected and the treatment team feels that the biopsy is an accurate reflection of true Breslow depth, then rebiopsy is not necessary
  9. * The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
  10. * Study intervention (surgery) must be completed within 120 days of the original diagnostic biopsy
  11. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
  12. * 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
  13. * Participants with a history of HIV infection are eligible
  14. * Participants can speak, read and write in English or Spanish
  1. * Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
  2. * The patient has already undergone wide local excision at the site of the primary index lesion
  3. * 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
  4. * Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
  5. * 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
  6. * 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
  7. * Planned adjuvant radiotherapy to the primary melanoma site after excision
  8. * Participant is unwilling or unable to comply with study procedures

Contacts and Locations

Study Contact

Wesley Yu, M.D.
CONTACT
503-418-9386
yuwe@ohsu.edu

Principal Investigator

Wesley Yu
PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

  • Wesley Yu, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

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