NCT00503919

Brief Summary

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images to histopathologic mapping of the cervical epithelium. Primary Objective:

  1. 1.To evaluate the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the presence of any neoplasia.
  2. 2.To evaluate mapping the cervix so that software can reconstruct the cervical epithelial map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as well as those from the Multi-spectral Digital Colposcopy (MDC).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 8, 2016

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

July 17, 2007

Last Update Submit

April 6, 2016

Conditions

Cervical Neoplasia

Keywords

CervixCervical dysplasiaCervical neoplasiaCervical intraepithelial neoplasiaMulti-spectral Digital ColposcopyMDCAcetic acidColposcopySpectroscopyFluorescence SpectroscopyAbnormal Pap Smear

Outcome Measures

Primary Outcomes (1)

  • Number of participants with abnormal cell detection before and after acetic acid/colposcopy using Multi-spectral Digital Colposcopy (MDC)

    Measurements of normal sites during colposcopy before and after the application of acetic acid using Multi-spectral Digital Colposcopy (MDC) images in vivo of the cervix both before and after acetic acid. Three images (white, blue, and green light) compared before and after acetic acid placement, the images may be compared to pathology obtained from a Pap Smear taken to evaluate the performance of the instrument.

    Participation limited to Colposcopy visit, anticipate study completion in one day

Study Arms (1)

MDC

EXPERIMENTAL

Multi-spectral Digital Colposcopy for Fluorescence Spectroscopy

Procedure: Multi-spectral Digital Colposcopy (MDC)

Interventions

Multi-spectral Digital Colposcopy (MDC)PROCEDURE

Use of a digital camera and a special light to take pictures of the cervix and vagina.

MDC

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18 years of age or older.
  • Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital, Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical Screening Clinics, Family Planning Clinics or Gynecology Clinics.
  • Patients must sign an informed consent indicating awareness of the investigational nature of the study.

You may not qualify if:

  • Patients will be considered ineligible if they are pregnant.
  • If they have a history of an abnormal Pap or a treatment to the cervix.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Andrea Milbourne, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 8, 2016

Record last verified: 2009-09