Grant Details
Grant Number: |
3R01CA087905-05S1 Interpret this number |
Primary Investigator: |
Moscicki, Anna-Barbara |
Organization: |
University Of California, San Francisco |
Project Title: |
Natural History of Cin2 in Adolescents |
Fiscal Year: |
2007 |
Abstract
With the introduction of the HPV vaccine, policies toward screening practices will need to be reevaluated
with a goal of achieving a reasonable balance between maximizing benefits, minimizing risks, and achieving
cost-effectiveness. Although current practice is to treat CIN 2 the same as CIN 3, many question this practice
in young women since these young women remain a vulnerable population to treatment side effects that are
related to fertility. In addition, understanding mechanisms that are related to CIN 2 regression are important
in developing treatment strategies. In a prospective study of adolescents and young women aged 13 to 24
years of age, our first aims are to:1a) define the rates of CIN 2 regression and examine the role of hormonal
contraceptives, estrogen and progesterone receptor expression, and mucosal mRNA markers of cellmediated
immunity (CMI) in regression of CIN-2 lesions. The second aim is to conduct a cost-effectiveness
analysis of alternative strategies for adolescents and young women with CIN 2 in the US. This will conducted
by 2a) Modifying a natural history model of cervical neoplasia in adolescents to explicitly include health
states that reflect CIN 2 and CIN 3 separately, and calibrate the model to the U.S. population; 2b) Integrating
the best available data, including the primary data collected in this study, to develop input model parameters
with special attention to age-specific probabilities in adolescents and young girls; 2c) To use the refined
model to estimate the short and long-term benefits, harms, and costs of alternative screening strategies for
adolescents and young women with CIN 2. Women who were recruited into the Kaiser Permanente Medical
Group of Northern California (KPMG-NC) study of CIN 2 (n=76) will be asked to continue follow-up. In
addition, 25 young women aged 13-24 years of age diagnosed with CIN 2 by histology at 7 participating
KPMG-NC Clinics will be asked to participate. The study proposes to observe young women with a biopsy
verified CIN-2 lesion at 4 month intervals with HPV testing, cytology and colposcopy, b) examine risk factors
using interview and chart review and c) examine estrogen and progesterone receptor expression and local
immune responses (IFN-y, IL-12, IL-10 and T-reg) by sampling of cervical tissue. The data we obtain on the
natural history of CIN 2 will be formally incorporated into a computer-based microsimulation model of cervical
neoplasia and cancer. This study will be paramount in the development of proper guidelines for screening
and triage of abnormal cytology and will give insight into immunologic and hormonal mechanisms associated
with CIN-2 development. Relevance: The data gathered from this study will be used develop formal costeffectiveness
analysis of alternative screening strategies for cervical neoplasia and cancer in adolescents in
the U.S. and specifically assess how best to modify cytology-based screening, utilize HPV diagnostics, and
tailor aoDrooriate follow-uo strategies for adolescents and vouna women diaanosed with CIN 2
Publications
None. See parent grant details.