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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505726 |
Purpose
The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Procedure: Reflectance Confocal Imaging |
Phase I |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN) |
| Enrollment: | 39 |
| Study Start Date: | November 2001 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Confocal Microscopy |
Procedure: Reflectance Confocal Imaging
Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
|
Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample.
Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)
Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor.
1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.
Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.
This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M.
D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Lyndon B. Johnson Hospital | |
| Houston, Texas, United States, 77030 | |
| U. T. Health Science Center | |
| Houston, Texas, United States, 77030 | |
| Canada, British Columbia | |
| British Columbia Cancer Research Center | |
| Vancouver, British Columbia, Canada | |
| Principal Investigator: | Michele Follen, MD, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Michele Follen, MD, MS, BA, PHD / Professor ) |
| Study ID Numbers: | ID01-555, CA82880 |
| Study First Received: | July 20, 2007 |
| Last Updated: | September 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00505726 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cervical Intraepithelial Neoplasia Cervical Cancer Reflectance Confocal Imaging Colposcopy |
|
Carcinoma in Situ Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
|
Neoplasms Neoplasms by Histologic Type Carcinoma in Situ |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
