Back to resultsA See and Treat Paradigm for Cervical Pre-cancer
Primary Purpose
Cervical Pre-cancer
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
transvaginal digital colposcope (TVDC)
Standard of care screening
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Pre-cancer
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
- Age 25 and greater
- Patients of all ethnic backgrounds will be included.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Children and subjects under 25.
Sites / Locations
- Duke University Medical Center
- AIIMS
- La Liga Contra el Cancer
- Kilimanjaro Christian Medical Centre
- University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transvaginal digital colposcope (TVCD)
standard of care screening
Arm Description
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
Outcomes
Primary Outcome Measures
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02477124
Brief Title
A See and Treat Paradigm for Cervical Pre-cancer
Official Title
A See and Treat Paradigm for Cervical Pre-cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pre-cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
514 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transvaginal digital colposcope (TVCD)
Arm Type
Active Comparator
Arm Description
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
Arm Title
standard of care screening
Arm Type
Active Comparator
Arm Description
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
Intervention Type
Device
Intervention Name(s)
transvaginal digital colposcope (TVDC)
Intervention Description
TVDC is a miniature colposcope used to obtain images of cervical tissue.
Intervention Type
Other
Intervention Name(s)
Standard of care screening
Intervention Description
Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope
Primary Outcome Measure Information:
Title
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
Time Frame
Up to approximately 10 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
Age 25 and greater
Patients of all ethnic backgrounds will be included.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Children and subjects under 25.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmala Ramanujam, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
AIIMS
City
New Delhi
Country
India
Facility Name
La Liga Contra el Cancer
City
Lima
Country
Peru
Facility Name
Kilimanjaro Christian Medical Centre
City
Moshi
Country
Tanzania
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Learn more about this trial
A See and Treat Paradigm for Cervical Pre-cancer
We'll reach out to this number within 24 hrs