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

Women With Abnormal Pap Smears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02767726
• Other study ID #: UPCC 02815
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms
• Women With Abnormal Pap Smears

Intervention

Device:
• non-invasive multimodal imaging

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of suspicious lesions identified		2 years