NCT00658190

Brief Summary

The purpose of this study is to assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2012

Enrollment Period

9.2 years

First QC Date

April 9, 2008

Last Update Submit

April 6, 2015

Conditions

Cervical Cancer

Keywords

Cervical cancer, automation, Internet, telecytology

Outcome Measures

Primary Outcomes (1)

  • Cervical cytology abnormal cases

    Identification of abnormalities compared to the initial interpretation

    At enrollment

Study Arms (1)

1

Women obtaining routine Pap tests for cervical cancer screening

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Females presenting to clinics at MGH or WRAMC for a Pap test

You may qualify if:

  • Female presenting to clinic for a Pap test for any reason

You may not qualify if:

  • Pregnant
  • Prisoners
  • Mentally unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20001, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Eichhorn JH, Brauns TA, Gelfand JA, Crothers BA, Wilbur DC. A novel automated screening and interpretation process for cervical cytology using the internet transmission of low-resolution images: a feasibility study. Cancer. 2005 Aug 25;105(4):199-206. doi: 10.1002/cncr.21098.

    PMID: 15937917BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • David C. Wilbur, MD

    MGH

    PRINCIPAL INVESTIGATOR

  • Barabara A Crothers, D.O

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pathologist

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 14, 2008

Study Start

October 1, 2003

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

April 7, 2015

Record last verified: 2012-04

Locations

US(2)