Back to resultsA Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Primary Purpose
Women With Abnormal Pap Smears
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-invasive multimodal imaging
Sponsored by
About this trial
This is an interventional screening trial for Women With Abnormal Pap Smears
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.
Exclusion Criteria:
- Pregnancy.
- Males (males do not have a cervix and thus cannot undergo colposcopy).
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Outcomes
Primary Outcome Measures
Number of suspicious lesions identified
Secondary Outcome Measures
Full Information
NCT ID
NCT02767726
First Posted
May 9, 2016
Last Updated
May 12, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02767726
Brief Title
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Official Title
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Study Start Date
January 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Abnormal Pap Smears
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
non-invasive multimodal imaging
Primary Outcome Measure Information:
Title
Number of suspicious lesions identified
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Exclusion Criteria:
Pregnancy.
Males (males do not have a cervix and thus cannot undergo colposcopy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Burkland, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
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