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Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250055
First Posted: November 7, 2005
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of New Mexico
  Purpose

In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance.

Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells.

Develop and implement quantitative and sensitive methods for measuring morphological properties.

Clinical measurements.


Condition Intervention
Cervix Cancer Procedure: Colposcopy, Spectroscopy, and Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions. [ Time Frame: 6 years ]

Estimated Enrollment: 100
Study Start Date: April 2004
Study Completion Date: January 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Colposcopy, Spectroscopy, and Biopsy
    During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.
Detailed Description:
Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with abnormal Pap smears who are referred for colposcopy.

Exclusion criteria include:

  • Anyone of the male sex since this study focuses on cervical cell abnormalities
  • Any woman who has had a hysterectomy, LEEP, or chemotherapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250055


Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Harriet Smith, MD University of New Mexico
  More Information

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00250055     History of Changes
Other Study ID Numbers: 1104C
First Submitted: November 3, 2005
First Posted: November 7, 2005
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University of New Mexico:
NIH
Non-Invasive diagnosis of cervical tissue
Los Alamos/NIH