Status:
COMPLETED
Spectroscopic Evaluation of Cervical Neoplasia
Lead Sponsor:
Guided Therapeutics
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Neoplasia
Eligibility:
FEMALE
16+ years
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...
Detailed Description
If you agree to take part in this study, spectroscopic measurements on your cervix will be made for research purposes, prior to your routine colposcopy examination. MEASUREMENT PROCEDURE: The doctor...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
1599 Patients enrolled
Trial Details
Trial ID
NCT00766701
Start Date
January 1 2003
End Date
September 1 2008
Last Update
October 6 2008
Active Locations (7)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72205
2
Orange Coast/Saddleback
Laguna Beach, California, United States, 92653
3
Saint Francis Hospital
Hartford, Connecticut, United States, 06112
4
University of Miami
Miami, Florida, United States, 33136