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Can a simple paper tool help melanoma patients make tough biopsy decisions?

NCT ID NCT07653087

Knowledge-focused Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a paper-based decision aid designed to help people with intermediate-risk melanoma decide whether to have a sentinel lymph node biopsy. The tool provides clear information about the procedure, its risks and benefits, and helps patients think about their personal preferences. Researchers want to see if using the aid reduces uncertainty and improves knowledge about the biopsy decision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Decision aid (paper-based informational tool)
What this could lead to
If effective, this decision aid could help patients and doctors make more confident, informed choices about sentinel lymph node biopsy for melanoma.
What could go wrong
This is a small, early-stage study focused on decision-making, not treatment outcomes. The tool may not reduce anxiety or improve decisions for all patients.

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 66 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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: 1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma. 2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered. 3. Patients with either: * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\<5%, 5-10%, or \>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling. 4. Willingness and ability to comply with study procedures. 5. Ability to provide informed consent. 6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk. Exclusion Criteria: 1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation. 2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis. 3. Inability to speak or read English. 4. Inability or unwillingness to provide informed consent. 5. Prisoners

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma (skin cancer) Sentinel lymph node biopsy (SLNB)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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