- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766701
Spectroscopic Evaluation of Cervical Neoplasia
Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 will first place a vaginal speculum and then perform the LightTouch Ã'® procedure (that looks at tissue from the cervix using light). The doctor will use a fresh single use contact tube (a tube attached to the LightTouch device that helps hold it in place) and apply it gently to your cervix. This will transmit light much like a flashlight. The light will either reflect or bounce immediately off your cervix or it will enter the skin for less than a second, and then return back to the LightTouch device. Each reading will take about 5-7 minutes, and up to two readings may be taken. You may also be asked to repeat the experimental test the same day, for example 2 to 3 hours after the first test, as part of another experimental procedure to study whether the device gives the same result twice in a row on the same woman (a repeatability study). If you agree to a second (LightTouch) procedure you will again have placement of the contact tube applied gently to your cervix and another test will be taken. This could take another 5 to 7 minutes of your time.
Whether you agree to do one of the experimental tests or both of the tests, following the LightTouch experimental procedure(s), you will have a Pap smear of the endocervix (the doctor will use a small plastic brush remove cells from the endocervix canal). We will also test for human papilloma virus (HPV). HPV is a virus that is sexually transmitted is associated with abnormal Pap smears. The doctor will use two separate vials for these tests, one to take your Pap smear and the other to take more cells for an HPV test. Once the doctor takes your Pap smear and HPV test. The doctor will do the colposcopy exam using a colposcope to look at the cervix more closely to check for abnormal areas. The doctor will also apply acetic acid and Lugols if required. The doctor may also perform biopsy (remove one or more tissue samples you're your cervix) for later examination by a pathologist. If considered necessary, an ECC (Endocervical Curettage scraping of cells from the inside of the endocervix) will be performed if an abnormal area is seen.
A video image (camera) will be used to capture locations of abnormal areas and compare with the readings from the spectroscopic image. Your overall study participation time will be approximately 30 minutes. If you are asked to participate in second test and agree, it will take place directly after the first test. The spectroscopy portion in which measurements are taken takes 5 to 7 minutes to complete. If you have the second study procedure this will take an additional 15-30 minutes making your overall participation time up to 60 minutes (one hour). You may be asked to re-test one time during the same visit if the information collected is bad because of movement or if the device did not work.
The results of the LightTouch test will be compared with the results of your colposcopy and biopsy. The results of the LightTouch test test will not be used to plan your treatment. If your biopsy results show any abnormal changes, your doctor will discuss treatment options with you.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas
-
-
California
-
Laguna Beach, California, United States, 92653
- Orange Coast/Saddleback
-
-
Connecticut
-
Hartford, Connecticut, United States, 06112
- Saint Francis Hospital
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
-
Augusta, Georgia, United States, 30912
- Medical College of Georgia
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: December 2008
|
December 2008
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.
Time Frame: Q1 2009
|
Q1 2009
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Flowers, MD, Emory University/Grady Hospital System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GT1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Neoplasia
-
Krankenhaus Barmherzige Schwestern LinzMedical University of ViennaCompletedCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2Austria
-
International Agency for Research on CancerKamenge University Hospital, Burundi University, BurundiCompleted
-
Columbia UniversityDelphi Devices BVCompleted
-
National Cancer Institute (NCI)Terminated
-
University Hospital, GenevaCompletedCervical Intra-epithelial Neoplasia Grade 1 or WorseSwitzerland
-
National Cancer Institute (NCI)TerminatedCervical Cancer | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3United States
-
Onconix, IncUnknownCervical Cancer | Cervical Intraepithelial Neoplasia III | Cervical Intraepithelial Neoplasia IIUnited States
-
National Cancer Institute (NCI)Active, not recruitingCervical Intraepithelial Neoplasia Grade 2/3 | High Grade Cervical Intraepithelial Neoplasia | Cervical Squamous Cell Carcinoma In Situ | Cervical Squamous Intraepithelial Neoplasia 2United States
-
Genexine, Inc.CompletedCervical Intraepithelial Neoplasia 3Korea, Republic of
-
Mithra PharmaceuticalsCompletedCervix Intraepithelial Neoplasia | Uterine Cervical NeoplasiaBelgium
Clinical Trials on Procedure: Spectroscopy and Digital Imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingTobacco Use Disorder | Fanconi Anemia | Lichen Planus | Oral Neoplasm | Erythroplakia | Premalignant Lesion | Oral Cavity and Lip Precancerous Condition | Oral Cavity LeukoplakiaUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompleted
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedHypoxia-Ischemia, Brain | Signs and SymptomsUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedAccessory; Breast TissueUnited States
-
OHSU Knight Cancer InstituteUnited States Department of Defense; Oregon Health and Science University; Portland...Completed
-
Indiana UniversityAmerican Society for Surgery of the HandTerminatedPain | Amputation | Amputation NeuromaUnited States
-
Sunnybrook Health Sciences CentreNot yet recruiting
-
Sunnybrook Health Sciences CentreNot yet recruitingBreast Cancer | Breast MassesCanada
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedBrain TumorUnited States
-
University of California, IrvineBeckman Laser Institute University of California Irvine; Chao Family Comprehensive...CompletedBreast CancerUnited States