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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01CA269192 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
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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 four 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.
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 previously reflected only Phase 1 of Aim 3 of the grant. Phase 1 of Aim 3 was originally included within NCT04998318. The details for Phase 2 of Aim 3 were added to this record in September 2025 after approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pocket Assisted Colposcopy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pocket Colposcope | Device | Each patient will receive treatment in order to prevent cervical cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the Pocket CARE in detecting pre-cancer | Sensitivity will be reported as a percentage | Day of imaging (Day 1) |
| Specificity of the Pocket CARE in detecting pre-cancer | Specificity will be reported as a percentage | Day of imaging (Day 1) |
| Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer | PPV will be reported as a percentage | Day of imaging (Day 1) |
| Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer | NPV will be reported as a percentage | Day of imaging (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Huchko, MD | Contact | 919-684-8111 | megan.huchko@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan Huchko, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Recruiting | Nairobi | Kenya |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |