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Major trial questions need for extra surgery in melanoma patients

NCT ID NCT07530887

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 people with melanoma can safely avoid a second surgery (re-excision) after the initial tumor is removed with clear margins. About 1,749 adults with stage pT1b to pT4b melanoma will be randomly assigned to either standard follow-up care including re-excision or no re-excision. The goal is to see if skipping the extra surgery affects cancer recurrence, survival, and quality of life.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,749 people

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

Started

Nov 2025

Expected to finish

Nov 2033

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients must be 18 years or older at time of consent * Patients must have an ECOG performance score between 0 and 2 * Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma * Histological subtypes that are eligible are: * Superficial Spreading Melanoma (SSM) * Nodular Melanoma (NM) * The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma * Patient must provide informed consent and comply with the treatment protocol and follow-up plan * Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator * A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented: * The patient has undergone potentially curative therapy for all prior malignancies * Life expectancy should be at least 5 years and * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies. Exclusion Criteria: * Non-cutaneous melanoma (uveal, mucosal) * Acral melanoma * Lentigo malignant melanoma (LMM) * Desmoplastic melanoma * Neurotropic melanoma * Spitz melanoma/malignant Spitz tumor melanoma * Satellites, in-transit melanomas or macroscopic melanoma metastases * Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP) * Other non-SSM or NM subtypes * Melanoma removed by shave excision, excogliation or core biopsy * Patient has already undergone a local flap reconstruction of the defect after excision of the primary * History of previous or concurrent (i.e., second primary) invasive melanoma * Multiple melanomas * Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB * Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years * History of organ transplantation

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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

    21 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

  • Alrijne Ziekenhuis

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, Netherlands

  • Catharina ziekenhuis

    NOT_YET_RECRUITING

    Eindhoven, Netherlands

  • Diakonessenhuis

    RECRUITING

    Utrecht, Netherlands

  • Dijklander Ziekenhuis

    NOT_YET_RECRUITING

    Hoorn, Netherlands

  • Flevoziekenhuis

    RECRUITING

    Almere Stad, Netherlands

  • Gelre ziekenhuizen

    RECRUITING

    Apeldoorn, Netherlands

  • Groene Hart Ziekenhuis

    NOT_YET_RECRUITING

    Gouda, Netherlands

  • Haaglanden Medisch Centrum

    RECRUITING

    The Hague, Netherlands

  • Haga Ziekenhuis

    NOT_YET_RECRUITING

    The Hague, Netherlands

  • Isala Ziekenhuis

    NOT_YET_RECRUITING

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    RECRUITING

    's-Hertogenbosch, Netherlands

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    NOT_YET_RECRUITING

    Rotterdam, Netherlands

  • Maastricht UMC

    NOT_YET_RECRUITING

    Maastricht, Netherlands

  • Martini ziekenhuis

    NOT_YET_RECRUITING

    Groningen, Netherlands

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, Netherlands

  • Rijnstate Ziekenhuis

    RECRUITING

    Arnhem, Netherlands

  • St. Antonius Ziekenhuis

    NOT_YET_RECRUITING

    Utrecht, Netherlands

  • Tergooi MC

    NOT_YET_RECRUITING

    Hilversum, Netherlands

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