NCT07653087Not yet recruiting
Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- University of Virginia
- Diseases
- Melanoma
- NCT number
- NCT07653087
What you commit to
- Study type: Interventional
- Planned participants: 66
- From Jun 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.
Other illness
- Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.
Other
- Inability to speak or read English.
- Inability or unwillingness to provide informed consent.
- Prisoners
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.