Using ultrasound to assess melanoma depth before surgery
Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma
This study is testing if using ultrasound can help doctors measure how deep melanoma is before surgery, so they can remove it more effectively in one go for patients suspected of having this skin cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT04702854 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ultrasound biomicroscopy in determining the Breslow index, which measures the depth of cutaneous melanoma. By obtaining this information prior to the first surgical resection, dermatologists aim to perform a complete resection and sentinel lymph node analysis in a single surgical procedure, potentially reducing the need for multiple surgeries. The study targets patients with a clinical suspicion of cutaneous melanoma who are 18 years or older and can provide informed consent. The goal is to improve treatment outcomes by providing timely and accurate staging of the cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical suspicion of cutaneous melanoma.
Not a fit: Patients who cannot undergo surgical resection of their melanoma or are considered vulnerable may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline surgical treatment for melanoma patients and improve their prognostic outcomes.
How similar studies have performed: While high-frequency ultrasound has been previously evaluated for this purpose with disappointing results, this study's approach using ultrasound biomicroscopy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical suspicion of cutaneous melanoma * Age ≥ 18 years * Social Security affiliation * Approval of patient and signature of informed consent form Exclusion Criteria: * Counter-indication to the surgical resection of the cutaneous melanoma * Vulnerable patient (Under-supervision patients or deprived of liberty patients)
Where this trial is running
Nice
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Nicolas AZULAY — Centre Hospitalier Universitaire de Nice
- Study coordinator: Nicolas AZULAY
- Email: azulay.n@chu-nice.fr
- Phone: 04 92 03 77 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.