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Principal Investigator: Jacqueline Linnes
Organization: PURDUE UNIVERSITY
Fiscal Year: 2024
Award: $392,991
Funding agency: National Cancer Institute
SUMMARY ABSTRACT
Although cervical cancer is an easily curable disease if detected early, it continues to claim the lives of
hundreds of thousands of women worldwide. Healthcare disparities have resulted in cervical cancer incidence
and mortality that are five times higher in low and middle income countries (LMICs) than in high-income countries.
In the United States, cervical cancer mortality rates are twice as high among rural women than their urban
counterparts. The wide disparity in cervical cancer incidence rates and deaths is attributed to both higher HPV
infection rates and a lack of accessible screening and treatment of pre-invasive cervical lesions.
The current standard of care in the US, a cytology-based Pap smear, requires resource intensive laboratory
and clinical specialists with a long turnaround time from sample collection to result. Alternatives, such as visual
inspection with acetic acid and emerging HPV-targeted tests, have poor specificity for cervical cancer, leading
to overtreatment that can cause complications including infertility and pre-term births and that further the burden
on limited healthcare resources. This proposal aims to create an integrated point-of-care screening test that can
be used by healthcare providers in under-resourced settings to obtain relevant clinical insights, including cervical
cancer risk stratification, and enable same-visit treatment of high risk cervical lesions.
Building on our preliminary development of a highly sensitive paper-based immunoassay to test for the key
cervical cancer biomarker, valosin containing protein (VCP), the objective of this proposal is to combine VCP
detection with three other known cervical cancer protein biomarkers, in a sensitive and specific single-step point-
of-care assay.
Specific milestones include:
1) Integrating and optimizing multiplex detection of cervical cancer biomarkers into a simple paper-based
sample-to-answer device.
2) Evaluating the operational and performance metrics of the test in retrospective cervical swab samples.
The outcome of this proposal will be a highly characterized point-of-care test with high sensitivity (95%) and
specificity (90%) to detect high-risk cervical intraepithelial neoplasia and invasive cervical cancer within 40
minutes. This affordable solution for cervical cancer screening and control programs will be applicable in LMICs
and will provide highly sensitive monitoring of cervical intraepithelial neoplasia in the US, where it will be
especially impactful in high-risk populations that are currently underserved by existing screening programs.
Terms: <2-dimensional><Acetic Acids><Active Follow-up><Antibodies><Area><Assay><BM28><Binding><Bioassay><Biological Assay><Biological Markers><Biomedical Engineering><Blinded><Blossoms><Buffers><CDCL1><CDK4I><CDKN2><CDKN2 Genes><CDKN2A><CDKN2A gene><CMM2><Cancerous><Cancers><Cannot achieve a pregnancy><Caring><Cause of Death><Cell Communication and Signaling><Cell Culture Techniques><Cell Devision Cycle-Like 1><Cell Signaling><Cervical><Cervical Cancer><Cervical Cancer Screening><Cervical Intraepithelial Neoplasia><Cervical Intraepithelial Neoplasms><Cervix Cancer><Cervix Intraepithelial Neoplasia><Cervix Uteri Intraepithelial Neoplasia><Cessation of life><Characteristics><Clinical><Cold Therapy><Country><Cryotherapy><Cyclin-Dependent Kinase Inhibitor 2A Gene><Cytology><Cytolysis><Death><Death Rate><Detection><Development><Devices><Diagnostic><Difficulty conceiving><Disease><Disorder><Disparities><Disparity><ELISA><Early Diagnosis><Economic Income><Economical Income><Ensure><Enzyme-Linked Immunosorbent Assay><Evaluation><Flowers><Goals><Gynecologic Oncologist><HPV><HPV Vaccination><HPV infection><Health Care Providers><Health Personnel><Healthcare><Healthcare Delivery><Healthcare Providers><Healthcare worker><Horseradish Peroxidase><Human Papilloma Virus><Human Papilloma Virus Vaccination><Human Papillomavirus><Human Papillomavirus Vaccination><Human Resources><Human papilloma virus infection><Human papillomavirus infection><INK4><INK4A><Immunoassay><Incidence><Income><Infectious Human Wart Virus><Infertility><Infrastructure><Intracellular Communication and Signaling><LMIC><Laboratories><Lesion><Low-resource area><Low-resource community><Low-resource environment><Low-resource region><Low-resource setting><Lysis><MCM2><MCM2 gene><MTS1><MTS1 Genes><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Neoplasm of the Cervix><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Cervix><Malignant Tumor of the Cervix Uteri><Malignant Uterine Cervix Neoplasm><Malignant Uterine Cervix Tumor><Malignant neoplasm of cervix uteri><Manpower><Marketing><Methods><Minichromosome Maintenance Complex Component 2><Mitotin><Molecular Interaction><Monitor><North Carolina><Northern Rhodesia><Nuclear Protein BM28><Orphan Disease><Outcome><Pap Test><Pap screening><Pap smear><Papanicolaou Smear><Papanicolaou Test><Paper><Pathologist><Patients><Performance><Plant Blooms><Policies><Predictive Value><Premature Birth><Prematurely delivering><Preterm Birth><Prevention><Primary Prevention><Process><Proteins><Rapid screening><Rare Diseases><Rare Disorder><Reagent><Receiver Operating Characteristics><Receiver Operator Characteristics><Refrigeration><Research Resources><Research Specimen><Resource-constrained area><Resource-constrained community><Resource-constrained environment><Resource-constrained region><Resource-constrained setting><Resource-limited area><Resource-limited community><Resource-limited environment><Resource-limited region><Resource-limited setting><Resource-poor area><Resource-poor community><Resource-poor environment><Resource-poor region><Resource-poor setting><Resources><Risk Reduction><Rural><Sampling><Scientist><Screening procedure><Sensitivity and Specificity><Signal Transduction><Signal Transduction Systems><Signaling><Specialist><Specificity><Specimen><Step Tests><Swab><TOP2><TOP2A><TOP2A gene><TP16><TP2A><TSG9A><Techniques><Technology><Testing><Therapeutic Cold><Time><United States><Universities><Uterine Cervix Cancer><Uterine Cervix Intraepithelial Neoplasia><VCP/p97><Vaccines><Visit><Visual><Woman><World Health Organization><Zambia><access to health care><access to healthcare><accessibility of health care><accessibility to health care><accessibility to healthcare><active followup><beta Actin><bio-engineered><bio-engineers><bio-markers><bioengineering><biologic marker><biological engineering><biological signal transduction><biomarker><cancer biomarkers><cancer disparity><cancer health disparity><cancer invasiveness><cancer markers><cancer progression><cancer-related health disparity><cell culture><cell cultures><cervical cancer early detection><cervical screening><clinical infrastructure><clinical relevance><clinically relevant><developmental><disparity in cancer><disparity in care><disparity in healthcare><early detection><early screening><enzyme linked immunoassay><fertility cessation><fertility loss><follow up><follow-up><followed up><followup><gold nano particle><gold nanoparticle><health and care delivery><health care><health care access><health care availability><health care delivery><health care disparity><health care inequality><health care inequity><health care personnel><health care service access><health care service availability><health care worker><health delivery systems><health provider><health services delivery><health workforce><healthcare access><healthcare accessibility><healthcare availability><healthcare disparity><healthcare inequality><healthcare inequity><healthcare personnel><healthcare service access><healthcare service availability><high risk><high risk group><high risk individual><high risk people><high risk population><incomes><infection rate><infertile><insight><instrumentation><low and middle-income countries><malignancy><medical personnel><mortality><mortality rate><mortality ratio><multiplex detection><nano gold><nanoGold><neoplasm progression><neoplasm/cancer><neoplastic progression><orphan disorder><over-treatment><overtreatment><p14ARF><p16 Genes><p16INK4 Genes><p16INK4A Genes><p16INK4a><p97-VCP protein><performance tests><personnel><point of care><point of care testing><precancer><precancer cervical detection><precancerous><premalignant><premature childbirth><premature delivery><preterm delivery><programs><protein biomarkers><protein markers><protein purification><rate of infection><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><risk stratification><risk-reducing><rural America><sample collection><scale up><screening><screening program><screening tools><screenings><skills><specimen collection><standard of care><stratify risk><treatment provider><tumor progression><two-dimensional><valosin containing protein p97><valosin-containing protein><valosine-containing protein><viral detection><virus detection><wart virus><β-Actin>