Point-of-care AI spectroscopy test to triage vulvar lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, non-interventional pilot aims to feasibility test the DermaSensor device on vulvar skin. Eligible participants are adults with biopsy-proven vulvar cancer or VIN who are planning excision at Mayo Clinic and may have up to two distinct lesions evaluated per patient. The study will apply the device to selected lesions to determine practicality of use, data collection, and potential triage value. No experimental treatment is given; the focus is on device feasibility and real-world operation. Results will inform future larger studies on non-invasive assessment of vulvar lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18
* Biopsy proven diagnosis of vulvar squamous cell carcinoma (SCC), human papillomavirus (HPV)-associated VIN 3, or HPV-independent differentiated vulvar intraepithelial neoplasia (VIN) planning surgical excision at Mayo Clinic in Rochester
* Ability to provide informed consent, including with the assistance of an in-person or virtual interpreter
* Multiple distinct lesions on the same patient may be included as distinct device applications, up to two non-contiguous lesions

Exclusion Criteria:

* Pregnancy
* Incarceration
* Lesion proximal to the hymen (no vaginal or peri-urethral mucosal lesions)
* Lesions at the anal verge
* Absence of residual lesion beyond prior biopsy or surgical site (device cannot be applied on a healing biopsy site or surgical scar)
* Lesion covered with excessive crust, erosion, or ulceration
* Previous treatment with CO2 laser, cavitational ultrasonic surgical aspiration (CUSA), cryotherapy, or other ablative techniques at the site of device application
* Previous treatment with vulvar radiation therapy at the site of device application

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Kelly H. Bruce, MD, MS — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.