NCT00941512

Brief Summary

This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Shorter than P25 for all trials

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

April 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
Last Updated

July 17, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

July 15, 2009

Last Update Submit

July 15, 2009

Conditions

Colposcopy

Keywords

Colposcopy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women identified with an abnormal Pap smear

You may qualify if:

  • Female
  • Negative pregnancy test
  • years and older
  • Presence of a cervix

You may not qualify if:

  • Pregnant
  • Absence of a cervix
  • Less than 18 years old
  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Uterine Cervix tissue

Study Officials

  • Daron G Ferris

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

April 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 17, 2009

Record last verified: 2009-07