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Trial Title:
Pocket Colposcopy Using CARE Algorithm
NCT ID:
NCT06458062
Condition:
Cervical Cancer
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
HPV testing
colposcopy
cervical cancer screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Pocket Colposcope
Description:
Each patient will receive treatment in order to prevent cervical cancer
Arm group label:
Pocket Assisted Colposcopy
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kenya Medical Research Institute
Address:
City:
Nairobi
Country:
Kenya
Contact:
Last name:
Francesca Odhiambo, MBcHB, MMed
Phone:
0799427912
Email:
fodhiambo@kemri-rctp.org
Start date:
December 1, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Kenya Medical Research Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06458062
