A See and Treat Paradigm for Cervical Pre-cancer

Sponsor

Duke University (Other)

Overall Status

Terminated

CT.gov ID

NCT02477124

Collaborator

(none)

514

Enrollment

Locations

Arms

Duration (Months)

102.8

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cervical Pre-cancer	Device: transvaginal digital colposcope (TVDC) Other: Standard of care screening	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

514 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A See and Treat Paradigm for Cervical Pre-cancer

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.	Device: transvaginal digital colposcope (TVDC) 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.	Other: Standard of care screening 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

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.

Device: transvaginal digital colposcope (TVDC)

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.

Other: Standard of care screening

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

Outcome Measures

Primary Outcome Measures

Concordance of the TVDC to standard of care, as measured by weighted kappa statistic [Up to approximately 10 minutes]
The level of agreement between the standard of care diagnosis and the diagnosis of the TVDC images will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27708
2	AIIMS	New Delhi		India
3	La Liga Contra el Cancer	Lima		Peru
4	Kilimanjaro Christian Medical Centre	Moshi		Tanzania
5	University Teaching Hospital	Lusaka		Zambia

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Nirmala Ramanujam, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT02477124

Other Study ID Numbers:

Pro00052865

First Posted:

Jun 22, 2015

Last Update Posted:

Jan 26, 2022

Last Verified:

Aug 1, 2021

Additional relevant MeSH terms:

Uterine Cervical Dysplasia

Study Results

No Results Posted as of Jan 26, 2022