A See and Treat Paradigm for Cervical Pre-cancer

May 16, 2023 updated by: Duke University
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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New Delhi, India
        • AIIMS
      • Lima, Peru
        • La Liga Contra el Cancer
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University Medical Center
      • Lusaka, Zambia
        • University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transvaginal digital colposcope (TVCD)
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.
TVDC is a miniature colposcope used to obtain images of cervical tissue.
Active Comparator: standard of care screening
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to approximately 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nirmala Ramanujam, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00052865

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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