Cervical Cancer Early Endpoints and Determinants

Completed

Conditions studied: Cervical Cancer, Cervical Intraepithelial, Neoplasia, CIN

In brief

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.

Key facts

Study ID

NCT00339989

Run by

National Cancer Institute (NCI)

People needed

3013

Starts

2003-09-12

Expected to finish

2020-03-11

Last updated by the study team

2020-03-13

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of Oklahoma — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.