Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00513123 |
Primary Objectives:
Condition | Intervention |
---|---|
Cervical Cancer |
Procedure: Colposcopy |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia |
Estimated Enrollment: | 114 |
Study Start Date: | September 2002 |
DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).
DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Nigeria, Oyo State | |
University College Hospital | |
Ibadan, Oyo State, Nigeria |
Principal Investigator: | Michele Follen, MD, PhD | U.T.M.D. Anderson Cancer Center |
Study ID Numbers: | GYN98-258 |
Study First Received: | August 7, 2007 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00513123 |
Health Authority: | United States: Institutional Review Board |
Digital Colposcopy for Fluorescence Cervical Intraepithelial Neoplasia Digital Colposcopy Cervical Cancer |
Cervical intraepithelial neoplasia Carcinoma in Situ Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type |