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Less may be more: smaller surgery for melanoma tested in 1,000-Patient trial

NCT ID NCT06673095

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • OHSU Knight Cancer Institute

    RECRUITING

    Portland, Oregon, 97239, United States

  • University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California, Davis

    NOT_YET_RECRUITING

    Davis, California, 95817, United States

  • University of Kentucky/Markey Cancer Center

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

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