A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Not Applicable
Terminated
- Conditions
- Women With Abnormal Pap Smears
- Registration Number
- NCT02767726
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
- Subjects are 18 years of age or older
- Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
- Subjects are women.
Exclusion Criteria
- Pregnancy.
- Males (males do not have a cervix and thus cannot undergo colposcopy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of suspicious lesions identified 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States