Cervical Neoplasia Clinical Trial
Official title:
The HPV Persistence and Progression (PaP) Cohort at Kaiser Permanente Northern California
Verified date | April 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- In most women, HPV infection does not cause symptoms and the infection goes away on its
own. In a small percentage of women, the HPV infection does not go away and sometimes
can result in cervical precancer or cancer.
- There are several different types of HPV. A better understanding of which types are
related to cervical precancer and cancer may help guide doctors in clinical management
of women who test positive for HPV and better understand why some women develop disease
while others do not.
Objectives:
- To determine whether certain types of HPV are more risky than others and if so, whether
they warrant separate detection in screening for cervical precancer and cancer.
- To determine if lasting infection by different HPV types carry different risk of
cervical precancer and cancer.
- To determine what viral and genetic factors influence the development of cervical
precancer and cancer.
- To evaluate new HPV tests and new biomarkers of cervical cancer risk.
Eligibility:
-Women 30 years of age and older who are in the cervical cancer screening program at the
Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a
random sample of women who tested negative for the virus are included.
Design:
-Data about participants genetic background and the type of carcinogenic HPV with which they
are infected are analyzed.
Status | Completed |
Enrollment | 131110 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: Women in KPNC aged 25 years or older who tested positive for HPV. Will also include a random sample of women who tested negative for HPV. EXCLUSION CRITERIA: Male. Children under 18. |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Northern California | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Gage JC, Sadorra M, Lamere BJ, Kail R, Aldrich C, Kinney W, Fetterman B, Lorey T, Schiffman M, Castle PE; PaP Cohort Study Group. Comparison of the cobas Human Papillomavirus (HPV) test with the hybrid capture 2 and linear array HPV DNA tests. J Clin Microbiol. 2012 Jan;50(1):61-5. doi: 10.1128/JCM.05989-11. Epub 2011 Nov 9. — View Citation
Lamere BJ, Castle PE, Fetterman B, Poitras N, Stanley M, Shieh J, Lorey T, Kinney W, Schiffman M. A study of borderline positive Hybrid Capture 2 tests in the Kaiser Permanente Northern California cervical screening program: evidence against retesting. J Virol Methods. 2013 Apr;189(1):77-9. doi: 10.1016/j.jviromet.2013.01.011. Epub 2013 Feb 4. — View Citation
Wentzensen N, Sun C, Ghosh A, Kinney W, Mirabello L, Wacholder S, Shaber R, LaMere B, Clarke M, Lorincz AT, Castle PE, Schiffman M, Burk RD. Methylation of HPV18, HPV31, and HPV45 genomes and cervical intraepithelial neoplasia grade 3. J Natl Cancer Inst. 2012 Nov 21;104(22):1738-49. doi: 10.1093/jnci/djs425. Epub 2012 Oct 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CIN2+/CIN3+/Cancer | Cervical histopathology; The detection of CIN2+,CIN3+, or cancer in histology results from tissue collected during cervical biopsies, excisional treatment or surgery. | Ongoing | |
Secondary | HPV Clearance | HPV DNA testing:A negative HPV test result or normal cytology during follow-up visits. | Ongoing |
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