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Cervical Cancer Early Endpoints and Determinants

NCT00339989 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3013

Last updated 2020-03-13

No results posted yet for this study

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 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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicolas Wentzensen, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-12
Primary Completion
2015-04-15
Completion
2020-03-11

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00339989 on ClinicalTrials.gov