Cervix

Clinical Epidemiology Unit (CEU) researchers are creating new cervical cancer screening approaches that are effective and efficient. For high resource settings, the investigators are designing a quick and cost-effective HPV genotyping assay to improve the detection and management of cervical cancer.

ALTS is a study of the clinical management of low-grade cervical cytologic abnormalities conducted by the Clinical Genetics Branch and the NCI Division of Cancer Prevention.

A collaborative study on colposcopic biopsy with aims to study cervical disease on the lesion level, optimize criteria for biopsy placement, and analyze the incremental benefit of taking multiple biopsies

A study to evaluate a cohort of HIV-infected women using two novel and potentially sustainable, lower-cost tests for accurate screening for cervical cancer

The Enduring Guidelines Effort is a process to provide regular updates to the 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. A consensus committee reviews new evidence from population-based and other studies to continually improve clinical management.

A population-based natural history study of HPV and cervical neoplasia launched with Costa Rican colleagues in 1993.

This study is designed to develop a cervical cancer risk prediction model incorporating clinical and laboratory covariates. The goal is to classify women’s risks of cervical intraepithelial neoplasia 2 (CIN 2), CIN 3, and cancer into strata upon which clinical management decisions can be based. Eight articles comprising a supplemental issue in the Journal of Lower Genital Tract Disease formed the early core of this effort.

Human Papillomavirus (HPV) Cervical Visualization Study

The HPV Vaccine Trial in Costa Rica (CVT) was a randomized, controlled phase III trial of the bivalent human papillomavirus-16/18 virus-like particle (VLP) vaccine. In addition to strong evidence for vaccine safety and efficacy, data from the trial demonstrated that three doses of the HPV vaccine may not be necessary, as similar vaccine efficacy against cervical HPV 16/18 infection was observed among women who received two, and even a single dose, after over 10 years of follow-up.

There is huge variability in risk of precancer and cancer conferred by different HPV types that is poorly explained. HPV type 16 is known to cause half of all cervical cancer cases worldwide, however, the specific reason for its carcinogenicity has been elusive. The HPV Genomics Project is designed to interrogate the relationship between sequence changes in the HPV genome and carcinogenicity.

Study of methylation of the HPV viral genome and risk of cervical intraepithelial neoplasia 3+ to prevent cervical cancer

Studies of human papillomavirus (HPV) natural history, genomics and risk assessment that led to advances in screening and clinical management

The Persistence and Progression Cohort (PaP Cohort) is a collaborative study with Kaiser Permanente Northern California to create a repository of specimens for natural history studies, HPV typing, methylation, and HPV variant genomics.

A comprehensive evaluation of candidate biomarkers for use in cervical cancer screening and triage.

A non-inferiority trial comparing immunogenicity from one dose of bivalent HPV vaccine in girls to three doses of quadrivalent vaccine in women.

The ESCUDDO study is a scientific evaluation of one or two doses of vaccine against human papillomavirus (HPV). If one dose of an HPV vaccine were found to be sufficient to reduce cervical cancer burden, we would expect more widespread vaccine uptake in the United States, and around the world, with vaccination programs being able to operate at an overall lower cost. Additionally, findings from the trial may make it possible for future evaluations of one-dose HPV vaccination to be smaller-scale immunogenicity trials, rather than efficacy trials, which could expedite expansion to other populations, ages, and vaccine formulations. Finally, these findings could transform the current vaccine development paradigm by providing the first example of a single-dose subunit vaccine that induces durable protective immunity.

The NCI is partnering with the George Washington University to evaluate novel biomarkers measured from self-collected samples in women undergoing cervical cancer screening.

Researchers are conducting the PRISMA study to determine if one dose of HPV vaccine is sufficient to reduce the risk of HPV infection in women, compared to no vaccine—the standard in the majority of the world. If one dose is sufficient, vaccinating women could help to accelerate the timeline for cervical cancer control, averting potentially millions of projected HPV-related cervical cancers expected over the coming decades as the population of the globe ages.

The NCI is partnering with the University of Mississippi Medical Center to evaluate risk of cervical precancer and to study novel biomarkers in women undergoing cervical cancer screening.

A study to comprehensively assess biomarkers of risk for progressive cervical neoplasia, and thus develop a new set of biomarkers that can distinguish those at highest risk of cervical cancer from those with benign infection