Cervical Neoplasia Clinical Trial
Official title:
Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
Verified date | October 2008 |
Source | Guided Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1599 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
United States | Medical College of Georgia | Augusta | Georgia |
United States | University of Texas | Dallas | Texas |
United States | Saint Francis Hospital | Hartford | Connecticut |
United States | Orange Coast/Saddleback | Laguna Beach | California |
United States | University of Arkansas | Little Rock | Arkansas |
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Guided Therapeutics | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial. | Q1 2009 | No |
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