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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of New Mexico.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250055
First received: November 3, 2005
Last updated: March 8, 2010
Last verified: July 2009
History of Changes
  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: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2004
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Harriet Smith, M.D.; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00250055     History of Changes
Other Study ID Numbers: 1104C
Study First Received: November 3, 2005
Last Updated: March 8, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013