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J Clin Virol. 2021 Dec;145:105014. doi: 10.1016/j.jcv.2021.105014. Epub 2021 Nov 03.

Development of a large biorepository of cervical specimens for the Improving Risk Informed HPV Screening study (IRIS).

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

Tina Raine-Bennett, Julia C Gage, Nancy Poitras, Malini Chandra, Nicole Varnado, Brian Befano, Mark Schiffman, Thomas Lorey, Nicolas Wentzensen

Affiliations

  1. Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, United States of America; Present affiliation: Medicines360, 353 Sacramento Street, Suite 300, San Francisco, CA, United States of America.
  2. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, DHHS, 9609 Medical Center Drive, MSC 9776 Bethesda, MD, United States of America.
  3. Regional Laboratory, Kaiser Permanente Northern California, 1725 Eastshore Hwy, Berkeley, CA, United States of America.
  4. Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, United States of America.
  5. Information Management Services Inc, 3901 Calverton Blvd #200, Calverton, MD, United States of America.
  6. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, DHHS, 9609 Medical Center Drive, MSC 9776 Bethesda, MD, United States of America. Electronic address: [email protected].

PMID: 34768232 DOI: 10.1016/j.jcv.2021.105014

Abstract

INTRODUCTION: Biomarkers of Human Papillomavirus (HPV) cervical carcinogenesis are critical to address questions of how to triage and manage women who screen positive for high-risk HPV (HrHPV) and identify those at highest cancer risk.

METHODS: We describe the development of a large biorepository of cervical specimens for the Improving Risk Informed HPV Screening Study (IRIS) using residual specimens collected in the regional laboratory from women aged 25 and older who had cervical cancer screening or follow-up testing with high-risk human papillomavirus (HrHPV) testing and liquid-based cytology (co-testing) at Kaiser Permanente Northern California (KPNC) from January 2016 to August 2018. Specimen selection, processing for long-term storage, follow-up tracking, consent and demographic and clinical characteristics of the women in the IRIS cohort are described.

RESULTS: Selecting from 897,680 women who had at least one co-test during the study period, we collected 199,403 baseline and 216,390 follow-up HrHPV and cytology specimens from a stratified random sample of 81,348 women, of which 3,428 (4.2%) opted out of the study and were excluded. The majority (79.9%) of the baseline specimens were from HrHPV-positive women. The mean age was 36 years, and the cohort is racially/ethnically diverse with 56% of women being Hispanic or non-white. Over two-thirds of the cohort were members of KPNC for two or more years prior to inclusion. Of the 77,920 women included in the cohort, 57,414 (73.7%) had at least one follow-up co-test.

CONCLUSION: Use of specimens from the biorepository will elucidate molecular mechanisms underlying HPV carcinogenesis and inform more effective screening and follow-up strategies.

Copyright © 2021. Published by Elsevier B.V.

Keywords: Biorepository; Cervical cancer screening; Cervical specimens; Human papillomavirus

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