Less may be more: smaller surgery for melanoma tested in 1,000-Patient trial
NCT ID NCT06673095
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether removing a smaller border of healthy tissue around a melanoma (narrow excision) works as well as the standard wider excision. About 1,000 adults with early-stage melanoma will be randomly assigned to one of the two surgeries. The goal is to see if narrow excision can reduce complications and improve quality of life without increasing the chance of the cancer coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical excision (narrow margin vs wide margin)
- What this could lead to
- If narrow excision works as well as wide excision, it could become the new standard for early-stage melanoma, reducing surgical side effects and improving recovery.
- What could go wrong
- This is a Phase 2/3 trial, so results are not yet proven. Narrow excision might lead to higher local recurrence rates, and the study is still recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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OHSU Knight Cancer Institute
RECRUITINGPortland, Oregon, 97239, United States
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University Hospitals Cleveland Medical Center
NOT_YET_RECRUITINGCleveland, Ohio, 44106, United States
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University of California, Davis
NOT_YET_RECRUITINGDavis, California, 95817, United States
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University of Kentucky/Markey Cancer Center
NOT_YET_RECRUITINGLexington, Kentucky, 40536, United States
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University of Michigan
NOT_YET_RECRUITINGAnn Arbor, Michigan, 48109, United States
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