Pocket Colposcopy Using CARE Algorithm

Cervical Cancer Clinical Trial

Official title:

Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458062
• Other study ID #: Pro00114753
• Secondary ID: 1U01CA269192
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2025
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Megan Huchko, MD
• Phone: 919-684-8111
• Email: megan.huchko[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Pocket colposcope has 510k FDA clearance and has been successfully used in ~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Description:

Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis. This record reflects Aim 3 of the grant.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1054
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age > 25 years old and < 65 years old

2. Sex: Female

3. Positive HPV test within past 6 months

Exclusion Criteria:

1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)

2. Women with a negative HPV test

3. Patients incapable of giving informed consent

4. Women with a history of cervical cancer

5. Pelvic exam concerning for cervical cancer or cervical infection

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infection
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Device:
• Pocket Colposcope
Each patient will receive treatment in order to prevent cervical cancer

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Kenya Medical Research Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the Pocket CARE in detecting pre-cancer	Sensitivity will be reported as a percentage	Day of imaging (Day 1)
Primary	Specificity of the Pocket CARE in detecting pre-cancer	Specificity will be reported as a percentage	Day of imaging (Day 1)
Primary	Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer	PPV will be reported as a percentage	Day of imaging (Day 1)