Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma

Starting soon · Not applicable

Conditions studied: Sentinel Lymph Node Biopsy (SLNB), Melanoma (Skin Cancer)

In brief

This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma. Sentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision. Patients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.

Key facts

Study ID

NCT07653087

Run by

University of Virginia

People needed

66

Starts

2026-06-01

Expected to finish

2028-01-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.
• Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.
• 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.
• Willingness and ability to comply with study procedures.
• Ability to provide informed consent.
• Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.

You may not qualify if…

• Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.
• Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.
• Inability to speak or read English.
• Inability or unwillingness to provide informed consent.
• Prisoners

Where it is running

• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.