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

NCT ID: NCT00250055

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Cervix Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Anyone of the male sex since this study focuses on cervical cell abnormalities
* Any woman who has had a hysterectomy, LEEP, or chemotherapy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harriet Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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1104C

Identifier Type: -

Identifier Source: org_study_id

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