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

March 9, 2024 updated by: University of New Mexico

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Harriet Smith, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimated)

November 7, 2005

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1104C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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