NCT00766701

Brief Summary

The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. The specific aims of the study are:

  • To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers.
  • To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements.
  • To evaluate the safety of spectroscopic measurement of cervical tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

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

January 1, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

5.7 years

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Cervical Neoplasia

Outcome Measures

Primary Outcomes (1)

  • Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia.

    December 2008

Secondary Outcomes (1)

  • A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.

    Q1 2009

Interventions

Procedure: Spectroscopy and Digital ImagingPROCEDURE

Procedure: Spectroscopy and Digital Imaging

Also known as: Spectroscopy, Digital Imaging

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Double-blind, Prospective, Safety-efficacy study

You may qualify if:

  • Age 16 or above
  • Able to read or understand and give informed consent
  • Scheduled for colposcopy
  • Pap test within 120 days
  • Willing to undergo a Pap test and HPV test on day of study

You may not qualify if:

  • Pregnancy
  • Menstruating on the day of colposcopy and CNDS test
  • Radiation therapy to her genitourinary system within 1 year
  • Prior hysterectomy
  • Congenital anatomical cervical variant (e.g., double cervix)
  • Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
  • Post-coital or other significant bleeding at the time of the exam
  • Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources
  • History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
  • Undergoing phototherapy
  • Recent use of photosensitizing agents, such as fluoroquinolones or retinoids).
  • Patients who are pregnant are not eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Orange Coast/Saddleback

Laguna Beach, California, 92653, United States

Location

Saint Francis Hospital

Hartford, Connecticut, 06112, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Texas

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

histology slides

MeSH Terms

Interventions

Spectrum AnalysisQuantitative Phase Imaging

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesMicroscopy, InterferenceMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Lisa Flowers, MD

    Emory University/Grady Hospital System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

January 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

US(7)