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Clinical Trials/NCT02767726
NCT02767726TerminatedNot Applicable

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

Abramson Cancer Center at Penn Medicine2 sites in 1 country4 target enrollmentStarted: January 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
4
Locations
2
Primary Endpoint
Number of suspicious lesions identified
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

Number of suspicious lesions identified

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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