Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears
Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
6 other identifiers
interventional
1,070
2 countries
2
Brief Summary
RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia. PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 1998
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 2, 2012
August 1, 2012
9.3 years
June 10, 2004
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fluorescent Measurements of Cervix
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Study Arms (1)
Fluorescence Spectroscopy
EXPERIMENTALInterventions
Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
Spectroscopy readings taken in 2 regions of cervix.
Eligibility Criteria
You may qualify if:
- Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
You may not qualify if:
- \) Pregnant individuals will be ineligible for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Helen Rhodes, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
April 1, 1998
Primary Completion
July 1, 2007
Study Completion
February 1, 2009
Last Updated
August 2, 2012
Record last verified: 2012-08