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Principal Investigator: Karen Sue Anderson
Organization: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
Fiscal Year: 2024
Award: $963,127
Funding agency: National Cancer Institute
Project Summary/Abstract
The goal of the EDRN Southwest Clinical Validation Center for Head and Neck Cancer is to improve oropharyngeal cancer
screening through the rigorous validation of salivary biomarkers. The scientific approach of our Center is based on several
fundamental principles. First, that human papillomaviral (HPV) infection and persistence induces carcinogenesis in the
oropharynx over decades, generating well-documented circulating and salivary viral nucleic acid and serologic biomarkers.
These biomarkers have not yet been tested in rigorous, prospective studies with centralized CLIA/CAP biomarker validation.
Second, the low incidence requires that effective screening paradigms for oropharyngeal cancers (OPC) use novel systems
for large-scale prospective studies using self-collection sampling, digital enrollment, and distributive systems to enable
enrollment in underserved communities. Third, that the clinical management of positive biomarkers be rigorously addressed.
Our proposal builds on our extensive experiences with cancer biomarker development, verification, validation, innovative
clinical study management, and expertise in HPV oropharyngeal cancer screening. Our previous results on HPV serologic
biomarkers have been confirmed in blinded phase 2 multicenter validation studies. Our results have shown that multiplexed
panels of IgG antibodies for HPV16 are required for adequate predictive value. Our Meso Scale Diagnostics, LLC. (MSD®)
team has fielded over 3,000 instruments worldwide, and over 700 commercially available biomarker assay kits. Their
expertise at serologic assay development led to one of their V-PLEX® serology panels being selected by Operation Warp
Speed as the basis of its standard binding assays for immunogenicity assessments in all funded Phase III clinical trials of
COVID vaccines. We will use the MSD MULTI-ARRAY® platform to migrate the HPV serologic markers for target clinical
applications in saliva. This represents an ongoing collaboration with experts in large-scale self-collection salivary biomarker
screening at Arizona State University, experts on head and neck cancer screening at Baylor University Medical Center, and
AT Still University (ATSU) School of Dentistry and Oral Health. We will generate high-quality well-characterized samples to
validate circulating and salivary biomarkers to enhance oropharyngeal cancer screening. Adhering to the principles of
PRoBE design, we will perform Phase 2 validation of HPV serology and nucleic acid testing with cancer patient and control
sera and saliva, followed by developing and testing the methodology needed to conduct a prospective Phase 4 salivary
screening study. We will provide a resource for expertise and clinical repository for the rigorous validation of salivary and
circulating biomarkers for cancer screening.
Terms: <2019-nCoV vaccine><7S Gamma Globulin><Academic Medical Centers><Address><Age><Antibodies><Area><Arizona><Assay><Back><Binding><Bioassay><Biological Assay><Biological Markers><Blinded><Blood><Blood Plasma><Blood Reticuloendothelial System><Blood Serum><COVID assay><COVID-19><COVID-19 assay><COVID-19 vaccine><COVID19 assay><CV-19><Cancer Cause><Cancer Control><Cancer Control Science><Cancer Etiology><Cancer Induction><Cancer Patient><Caring><Cervical Cancer><Cervical Cancer Screening><Cervix Cancer><Clinical><Clinical Evaluation><Clinical Management><Clinical Research><Clinical Study><Clinical Testing><Collaborations><Collection><Controlled Clinical Trials><Coronavirus Infectious Disease 2019><DNA><Data><Deoxyribonucleic Acid><Detection><Development><Diagnosis><Diagnostic><Dorsum><Dryness><EDRN><ELISA><Early Detection Research Network><Early Diagnosis><Enrollment><Enzyme-Linked Immunosorbent Assay><Feasibility Studies><Fingers><Foundations><Funding><Gender><General Population><General Public><Geographic Area><Geographic Locations><Geographic Region><Geographical Location><Goals><HNSCC><HPV><HPV + oropharyngeal carcinoma><HPV 16><HPV Vaccination><HPV associated HNSCC><HPV detection><HPV driven HNSCC><HPV driven head and neck cancer><HPV induced cancer><HPV malignancy><HPV mediated oropharynx cancer><HPV oropharyngeal cancer><HPV positive><HPV positive oropharyngeal cancer><HPV positive oropharynx cancer><HPV related oropharyngeal cancer><HPV related oropharyngeal carcinoma><HPV screening><HPV(+)><HPV(+) HNSCC><HPV(+) head and neck squamous cell carcinoma><HPV+><HPV+ HNSCC><HPV+ OPC><HPV+ cancer><HPV+ head and neck cancers><HPV+ oropharyngeal cancer><HPV-16><HPV-OPC><HPV-Related Malignancy><HPV-associated cancer><HPV-associated head and neck cancer><HPV-associated head and neck squamous cell carcinoma><HPV-associated malignancy><HPV-associated oropharyngeal cancer><HPV-driven oropharyngeal cancer><HPV-positive HNSCC><HPV-positive head and neck cancers><HPV-related HNSCC><HPV-related OPC><HPV-related cancer><HPV-related head and neck squamous cell carcinoma><HPV-related oropharyngeal cancer><HPV16><Head and Neck Cancer><Head and Neck Carcinoma><Head and Neck Squamous Cell Carcinoma><High Risk Woman><Home><Human><Human Papilloma Virus><Human Papilloma Virus Vaccination><Human Papilloma Virus detection><Human Papilloma Virus screening><Human Papilloma Virus-Related Malignancy><Human Papilloma Virus-Related Malignant Neoplasm><Human Papilloma Virus-associated cancer><Human Papilloma Virus-associated malignancy><Human Papilloma Virus-related cancer><Human Papillomavirus><Human Papillomavirus Vaccination><Human papilloma virus type 16><Human papillomavirus 16><Human papillomavirus cancer><Human papillomavirus driven HNSCC><Human papillomavirus driven head and neck cancer><Human papillomavirus driven oropharyngeal cancer><Human papillomavirus induced cancer><Human papillomavirus malignancy><Human papillomavirus related oropharyngeal carcinoma><Human papillomavirus type 16><Human papillomavirus- related oropharyngeal cancer><Human papillomavirus-Related Malignancy><Human papillomavirus-Related Malignant Neoplasm><Human papillomavirus-associated oropharyngeal cancer><IgG><Immune><Immunes><Immunoglobulin G><Incidence><Individual><Infection><Infectious Human Wart Virus><Infrastructure><Laboratories><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Head and Neck Neoplasm><Malignant Neoplasm of the Cervix><Malignant Oropharyngeal Neoplasm><Malignant Oropharyngeal 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><Methodology><Methods><Modern Man><Molecular Interaction><Morbidity><Morbidity - disease rate><National Detection Research Network><Newly Diagnosed><Nucleic Acid Amplification Tests><Nucleic Acid Testing><Nucleic Acids><Oncogene Products><Oncogene Proteins><Oncoproteins><Oral health><Oropharnyx Cancers><Oropharyngeal><Oropharyngeal Cancer><Oropharyngeal Carcinoma><Oropharynx><Oropharynx Cancer><Oropharynx Carcinoma><Oropharynxs><Participant><Patients><Peer Review Grants><Performance><Phase><Phase 3 Clinical Trials><Phase III Clinical Trials><Plasma><Plasma Serum><Population><Predicting Risk><Predictive Value><Prevalence><Prospective Studies><Publications><Reagent><Recurrent Malignant Neoplasm><Recurrent Malignant Tumor><Research><Research Design><Research Institute><Research Resources><Research Specimen><Resources><Reticuloendothelial System, Serum, Plasma><Risk><Risk Assessment><SARS-CoV-2 assay><SARS-CoV-2 vaccine><SARS-coronavirus-2 vaccine><SCCHN><Saliva><Salivary><Sampling><School Dentistries><School Dentistry><Scientific Publication><Screening for cancer><Serology><Serology test><Serum><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccine><Specimen><Speed><Spottings><Study Type><System><Technology><Testing><Texas><Universities><University Medical Centers><Uterine Cervix Cancer><Validation><Viral><advanced disease><advanced illness><ages><aggressive therapy><aggressive treatment><anti-cancer research><assay development><at-risk females><at-risk women><bio-markers><biobank><biologic marker><biomarker><biomarker development><biomarker performance><biomarker utility><biomarker validation><biorepository><blood-based biomarker><blood-based marker><cancer biomarkers><cancer markers><cancer prevention><cancer recurrence><cancer research><carcinogenesis><cervical cancer early detection><cervical screening><circulating biomarkers><circulating markers><clinical applicability><clinical application><clinical test><cohort><comparative><coronavirus disease 2019><coronavirus disease 2019 assay><coronavirus disease 2019 vaccine><coronavirus disease assay><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus infectious disease-19><dental health><depository><design><designing><developmental><digital><early cancer detection><early detection><enroll><enzyme linked immunoassay><experience><feasibility testing><females at high risk><forecasting risk><geographic site><head and neck squamous carcinoma><head and neck squamous cell cancer><head/neck cancer><high risk females><homes><human papilloma virus 16><human papilloma virus+ head and neck squamous cell carcinoma><human papillomavirus +><human papillomavirus associated head and neck cancer><human papillomavirus associated head and neck squamous cell carcinoma><human papillomavirus associated malignancy><human papillomavirus driven head and neck squamous cell carcinoma><human papillomavirus induced head and neck squamous cell carcinoma><human papillomavirus mediated oropharynx cancer><human papillomavirus positive><human papillomavirus positive HNSCC><human papillomavirus positive head and neck cancers><human papillomavirus positive head and neck squamous cell carcinoma><human papillomavirus positive oropharyngeal cancer><human papillomavirus positive oropharyngeal carcinoma><human papillomavirus positive oropharynx carcinoma><human papillomavirus related head and neck squamous cell carcinoma><human papillomavirus+ oropharyngeal cancer><human papillomavirus-associated cancer><human papillomavirus-related cancer><immunogenicity><improved><innovate><innovation><innovative><instrument><malignant head and neck tumor><malignant oropharynx neoplasm><malignant oropharynx tumor><marker validation><men><migration><mortality><nCoV vaccine><nCoV-19 vaccine><nCoV19 vaccine><novel><operation><operations><oral HPV-positive HNSCC><oral HPV-positive head and neck cancers><oral human papillomavirus positive head and neck cancers><oral human papillomavirus positive head and neck squamous cell carcinoma><oral pharyngeal><patient population><peripheral blood><phase III protocol><precancer cervical detection><predict risk><predict risks><predicted risk><predicted risks><predicting risks><predictive risk><predicts risk><presence of HPV><presence of human papillomavirus><programs><prospective><public health priorities><repository><research clinical testing><response><risk prediction><risk predictions><saliva assay><saliva based assay><saliva based test><saliva diagnostic><saliva sample><saliva test><salivary assay><salivary diagnostics><salivary sample><salivary test><sample collection><screening><screening cancer patients><screening program><screenings><serological marker><serology assay><severe acute respiratory syndrome coronavirus 2 assay><specimen collection><study design><success><type 16 Human papilloma virus><type 16 Human papillomavirus><under served community><underserved community><vaccine against 2019-nCov><vaccine against COVID-19><vaccine against SARS-CoV-2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine candidates against SARS-CoV-2><vaccine for novel coronavirus><vaccines preventing COVID><vaccines to prevent COVID><validation studies><validations><wart virus><women at high risk>