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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014