Status:
COMPLETED
Cervical Cancer Early Endpoints and Determinants
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Cervical Intraepithelial
Eligibility:
FEMALE
18-120 years
Brief Summary
This study, conducted by the National Cancer Institute and the University of Oklahoma, will look for changes in cervix cells and other samples that may be signs of cervical disease. Human papilloma vi...
Detailed Description
For the past twenty years, large epidemiologic natural history studies have played a crucial role in achieving our current understanding of cervical neoplasia. We now know that human papillomavirus (H...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All women who are referred for cervical colposcopy to the University of Oklahoma will be considered eligible for the study. These women will be categorized into four groups: (i) cancer, (ii) precancer, (iii) HPV-infected, and (iv) normal. Cancers will be limited to women diagnosed with early cancer (Stage 1-2) to minimize potential disease effects. Precancers will be defined as women diagnosed histologically with cervical intraepithelial neoplasia 3 (CIN3). This is a highly specific and well-reproduced diagnosis which effectively represents carcinoma in situ. All women testing DNA positive for any of the 13 known oncogenic HPV types (HPV-infected), but not diagnosed with CIN3 or cancer (all stages) will be placed in the HPV-positive group. This group will therefore encompass all HPV-infected women diagnosed with either cervical intraepithelial neoplasia 1 (CIN1), CIN2, low grade squamous intraepithelial lesion (LSIL), atypical squamous cells of undetermined significance (ASCUS), atypical glandular cells of underdetermined significance (AGUS), or found cytologically normal. Women referred to the colposcopy clinic but found to be negative for oncogenic HPV and normal upon histological diagnoses will be eligible as normal controls; this approach will be an ethical method for collecting biopsies from essentially "normal" women as there are many benign "look alike" conditions that are ruled out in colposcopy clinics. While this group may not be a random sample of the general population, the use of specimens from these women as controls will ensure a group of women who are truly confirmed as having no neoplasia.
- EXCLUSION CRITERIA:
- Women attending the clinic solely for vaginal colposcopies will be excluded from the study. Women who are under 18 years of age or pregnant at the visit will also be excluded from the study. In addition, women who have had prior treatment (women coming to the clinic for a follow-up visit subsequent to treatment (women coming to the clinic for a follow-up visit subsequent to treatment or women coming for their initial clinic visit following pretreatment with chemotherapy or radiation) will be excluded. All women with known HIV or AIDS will be excluded from the study. This information will not be readily available unless the woman has previously been seen at the University of Oklahoma clinic. This event is considered rare; recent studies of HIV and AIDS by the University of Oklahoma from the same population have been terminated due to the lack of HIV/AIDS detected in the population.
Exclusion
Key Trial Info
Start Date :
September 12 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
3013 Patients enrolled
Trial Details
Trial ID
NCT00339989
Start Date
September 12 2003
End Date
March 11 2020
Last Update
March 13 2020
Active Locations (1)
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1
University of Oklahoma
Oklahoma City, Oklahoma, United States