Pocket Colposcopy Using CARE Algorithm

Not Applicable

Not yet recruiting

• Conditions: HPV Infection; Cervical Cancer
• Interventions: Device: Pocket Colposcope

• 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 Aim 3 of the grant.

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Study Start: 2024-12-01
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1054

Inclusion Criteria

1. Age > 25 years old and < 65 years old
2. Sex: Female
3. Positive HPV test within past 6 months

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pocket Assisted Colposcopy	Pocket Colposcope	Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion.

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

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Nairobi, Kenya