Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435214
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2007-02-13
Brief Title:
Human Papillomavirus HPV and Risk of Cervical Precancer and Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The HPV Persistence and Progression PaP Cohort at Kaiser Permanente Northern California
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 CIN3cancer 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 60000 baseline specimens from the following sub-populations 1 approximately 40000 HPV positives and a random population sample of 4000 baseline specimens from women aged 30 years and older 2 approximately 5000 HPV-orcytology-positives and random population sample of 2000 baseline specimens from women aged 25-29 years of age and 3 approximately 5000 HPV-or cytology-positives and random population sample of 2000 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 1030954 over 5 years The de novo cost of screening this population to identify approximately 50000 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
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 60000 baseline specimens from the following sub-populations 1 approximately 40000 HPV positives and a random population sample of 4000 baseline specimens from women aged 30 years and older 2 approximately 5000 HPV-orcytology-positives and random population sample of 2000 baseline specimens from women aged 25-29 years of age and 3 approximately 5000 HPV-or cytology-positives and random population sample of 2000 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 1030954 over 5 years The de novo cost of screening this population to identify approximately 50000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-C-N079 | None | None | None |