Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection

Summary

Precancerous lesions of the cervix occur frequently and are treatable. This justifies a population-based screening program. Following an abnormal Pap smear, patients are referred for a colposcopic exam to confirm the presence/stage of disease and select appropriate treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give 'false positive' results (resulting in overtreatment). We are testing a device called a 'multispectral digital colposcope' to determine whether it is more effective at detecting precancerous cervical lesions than existing tools. Success in our study will make diagnoses more accurate and reduce the costs associated with unnecessary treatments.

Conditions

• Cervical Cancer
• Precancerous Condition

Interventions

DEVICE

Multispectral Digital Colposcope (MDC)

The MDC has 2 components: an optical probe \& a multispectral colposcope. The optical wand makes use of fluorescence \& reflectance spectroscopy; a light is shone on the cervix and the wand reports what it sees to a computer. Since cancer \& healthy cells interact differently with light, a computer can detect abnormalities. The multispectral colposcope is based on a conventional colposcope, which is already widely used. However, it is also able to produce fluorescence \& polarized reflectance images of the entire cervix. Computer analysis of these images can detect abnormalities on the cervix, defining their location and shape. This trial involves combined analysis of MDC data. This may lead to more effective diagnosis of cervical abnormalities. The MDC will be used with standard care for patients presenting with cervical abnormalities (as detected by a Pap test). The MDC will not be used to guide patient management decisions. All study subjects will receive this same intervention.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Texas Tech University Health Sciences Center

  collaborator OTHER

• Brookdale University Hospital Medical Center

  collaborator OTHER

• William Marsh Rice University

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• British Columbia Cancer Agency

  lead OTHER

Principal Investigators

• Michele Follen, MD, PhD · Brookdale Hospital and Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2016-09-01

Completion

2016-11-09

Countries

• United States
• Canada

Study Locations