Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer
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|ClinicalTrials.gov Identifier: NCT00435214|
Recruitment Status : Recruiting
First Posted : February 14, 2007
Last Update Posted : March 21, 2018
|First Submitted Date||February 13, 2007|
|First Posted Date||February 14, 2007|
|Last Update Posted Date||March 21, 2018|
|Start Date||January 29, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||CIN2+/CIN3+/Cancer [ Time Frame: Ongoing ]
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00435214 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||HPV Clearance [ Time Frame: Ongoing ]
HPV DNA testing
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer|
|Official Title||The HPV Persistence and Progression (PaP) Cohort at Kaiser Permanente Northern California|
-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.
-Data about participants genetic background and the type of carcinogenic HPV with which they are infected are analyzed.
The carcinogenicity of the 15 HPV types with carcinogenic potential varies greatly. We wish to clarify clinical utility of carcinogenic HPV DNA testing in women 21 and older by understanding the unique properties of individual HPV genotypes for viral persistence and progression. Specifically, we seek to understand the timing and determinants of viral clearance versus persistence and, given persistence, the risk of progression to CIN3/cancer (greater than or equal to CIN3) among women infected with each type of carcinogenic HPV genotype at the ages when cancer occurs. The relevant natural history data are lacking. There are no NCI or other cohorts in which these and other questions are being adequately addressed.
Kaiser Permanente Northern California (KPNC) routinely uses a FDA-approved pooled-HPV genotype DNA test for carcinogenic HPV (Hybrid Capture 2 [HC2], Qiagen Corporation, Gaithersburg, MD) as an adjunct to cytology for cervical cancer screening in women 30 and older and as a triage for immediate colposcopy for women with equivocal Pap results at all ages. We are teaming with 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-orcytology-positives 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. We will use efficient sampling designs to achieve high power with minimal laboratory analyses, with specimens selected for testing based on clinical outcomes ascertained by linkage to the Kaiser cytology and histology databases and KPNC s active yearly follow-up of all HC2-positive women. We plan to "follow" women for three years after their enrollment in 2007-8 by banking their residual specimens collected at their return visits; longer follow-up would likely be biased by extensive censoring due to treatment.
Extremely low-cost specimen accrual, computerized follow-up using the KPNC databases, and leveraged funding will make this cohort highly cost-effective, with a proposed budget of $1,030,954 over 5 years. The de novo cost of screening this population to identify approximately 50,000 HPV-positive women 21 and older, which is performed by KPNC as part of routine screening and at no cost to us, is approximately $50 million. The clinical follow-up, cytology, and histologic diagnoses cost millions more. We can obtain genotyping and variant testing without cost to the Division of Cancer Epidemiology and Genetics (DCEG), via collaborations and the aforementioned Cooperative Agreement. The major costs are for personnel to save and handle the specimens, extraction of clinical and questionnaire data, and to offer women whose specimens have been banked an opt-out for use of the specimens.
|Study Design||Observational Model: Cohort
Time Perspective: Other
|Target Follow-Up Duration||Not Provided|
|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.|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
Children under 18.
|Ages||21 Years to 100 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999907079
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 6, 2017|