Pocket Colposcopy Using CARE Algorithm
- Conditions
- HPV InfectionCervical Cancer
- Registration Number
- NCT06458062
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed 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 Phase 1 of Aim 3 of the grant. Phase 2 of Aim 3 will be added once approved. Phase 1 of Aim 3 was previously included within NCT04998318.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1054
- Age > 25 years old and < 65 years old
- Sex: Female
- Positive HPV test within past 6 months
- Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
- Women with a negative HPV test
- Patients incapable of giving informed consent
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sensitivity of the Pocket CARE in detecting pre-cancer Day of imaging (Day 1) Sensitivity will be reported as a percentage
Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer Day of imaging (Day 1) PPV will be reported as a percentage
Specificity of the Pocket CARE in detecting pre-cancer Day of imaging (Day 1) Specificity will be reported as a percentage
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Kenya Medical Research Institute
🇰🇪Nairobi, Kenya
Kenya Medical Research Institute🇰🇪Nairobi, KenyaFrancesca Odhiambo, MBcHB, MMedContact0799427912fodhiambo@kemri-rctp.org