High Resolution Digital Imaging of the Uterine Cervix

This study has been completed.
Sponsor:
Collaborators:
Instituto National de Edfermedades Neoplasicas
Eisenhower Army Medical Center
Information provided by:
STI-Medical Systems
ClinicalTrials.gov Identifier:
NCT00941512
First received: July 15, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition
Colposcopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigation to Correlate High Resolution Digital Images of the Uterine Cervix With Histopathology

Further study details as provided by STI-Medical Systems:

Biospecimen Retention:   Samples Without DNA

Uterine Cervix tissue


Enrollment: 112
Study Start Date: April 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women identified with an abnormal Pap smear

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Absence of a cervix
  • Less than 18 years old
  • Male
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941512

Sponsors and Collaborators
STI-Medical Systems
Instituto National de Edfermedades Neoplasicas
Eisenhower Army Medical Center
Investigators
Principal Investigator: Daron G Ferris Georgia Regents University
  More Information

No publications provided

Responsible Party: Jody Oyama, STI Medical Systems
ClinicalTrials.gov Identifier: NCT00941512     History of Changes
Other Study ID Numbers: 2005-1
Study First Received: July 15, 2009
Last Updated: July 15, 2009
Health Authority: Peru: Ministry of Health

Keywords provided by STI-Medical Systems:
Colposcopy

ClinicalTrials.gov processed this record on April 22, 2014