A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Abramson Cancer Center at Penn Medicine1 site in 1 country4 target enrollmentJanuary 2016

ConditionsWomen With Abnormal Pap Smears

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Women With Abnormal Pap Smears
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 4
Locations: 1
Primary Endpoint: Number of suspicious lesions identified
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

April 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

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.