Cervical Cancer Early Endpoints and Determinants

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 virus, or HPV, is a common infection of the genitalia in women that usually goes away by itself. If HPV infection does not go away, it might turn into cancer of the cervix, although this is rare. This study will examine why many HPV infections go away and why a few persist and lead to cervical cancer. Women 18 years of age and older who are referred for colposcopy (examination of the vagina and cervix using an instrument with a magnifying lens) at the University of Oklahoma following Pap smear diagnosis may be eligible for this study. Women will be in one of the following diagnostic categories: * Cancer: Stage 1-2 only. * Precancer: Cervical intraepithelial neoplasia (CIN3). * HPV-infected: Positive for any of the 13 known cancer-causing HPV types, but not diagnosed with cancer or CIN3. * Normal: Negative for cancer-causing HPV and normal tissue laboratory results. Participants will undergo the following procedures: * Questionnaire: Covers demographic information (such as age, race, ethnicity, marital status, etc.), pregnancy history, menstrual and sexual history, contraceptive history, hormone medication history, medical history, smoking history, physical development, family history, and health care access. * Blood test: 2 tablespoons of blood drawn. * Colposcopy. * Procedure to collect a sample of cervical cells and fluids for HPV testing and research.

Sex

Female

Minimum age

18 Years

Maximum age

120 Years

* 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.

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• DERIVEDLiu AH, Walker J, Gage JC, Gold MA, Zuna R, Dunn ST, Schiffman M, Wentzensen N. Diagnosis of Cervical Precancers by Endocervical Curettage at Colposcopy of Women With Abnormal Cervical Cytology. Obstet Gynecol. 2017 Dec;130(6):1218-1225. doi: 10.1097/AOG.0000000000002330. PMID 29112672