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

NCT ID: NCT02767726

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Women With Abnormal Pap Smears

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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non-invasive multimodal imaging

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Burkland, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 02815

Identifier Type: -

Identifier Source: org_study_id

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