Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer

NCT00435214 | Completed

• 2 other identifiers: 99990707907-C-N079
• Study Type: observational
• Target: 131,110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Neoplasia

Keywords

Cytology; papilloma virus; CIN; Screening; Cervix; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HPV Clearance

  Ongoing

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We are teaming with Kaiser Permanente Northern California (KPNC) to create a carcinogenic HPV-positive cohort (HPV Persistence and Progression Cohort or PaP Cohort) for investigating the natural history of HPV genotypes. Specifically, we will store approximately 60,000 baseline specimens from the following sub-populations: 1) approximately 40,000 HPV positives and a random population sample of 4,000 baseline specimens from women aged 30 years and older; 2) approximately 5,000 HPV-or-cytologypositives and random population sample of 2,000 baseline specimens from women aged 25-29 years of age; and 3) approximately 5,000 HPV-or cytology-positives and random population sample of 2,000 baseline specimens from women aged 21-24 years of age.

You may qualify if:

• 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.

You may not qualify if:

• Male.
• Children under 18.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Related Publications (3)

• 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.

  PMID: 22075592 BACKGROUND

• 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.

  PMID: 23093560 BACKGROUND

• 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. No abstract available.

  PMID: 23384678 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Discarded cervical Pap test specimens

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mark H Schiffman, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: January 29, 2007
• Primary Completion: April 1, 2020
• Study Completion: April 30, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (1)