Recruiting

Narrow Excision vs. Wide Excision

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06673095

Conditions

Clinical Stage IA Cutaneous Melanoma AJCC v8

Clinical Stage IB Cutaneous Melanoma AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Excision

Excision

Survey Administration

Study Details

Brief 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.

Conditions

Clinical Stage IA Cutaneous Melanoma AJCC v8

Clinical Stage IB Cutaneous Melanoma AJCC v8

Study ID

NCT06673095

Start date

Dec 11, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
  • The patient has already undergone wide local excision at the site of the primary index lesion
  • 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
  • Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
  • Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
  • 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
  • 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
  • Planned adjuvant radiotherapy to the primary melanoma site after excision
  • Participant is unwilling or unable to comply with study procedures

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Excision

Undergo narrow margin excision

Excision

Undergo wide margin excision

Survey Administration

Ancillary studies

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paige Smith

503-418-4268smitpaig@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Paige Smith

503-418-4268smitpaig@ohsu.edu

Principal Investigator:

Noah Hornick, M.D.

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-05-27.