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NCT06458062 | NOT YET RECRUITING | Cervical Cancer

Pocket Colposcopy Using CARE Algorithm
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.

Condition or disease

Cervical Cancer

HPV Infection

Intervention/treatment

Pocket Colposcope

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 1054 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 65 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Pocket Colposcopy Using CARE Algorithm

Location Details

NCT06458062

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How to Participate

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Locations

Not yet recruiting

Kenya,

Kenya Medical Research Institute

Nairobi, Kenya,