This proposal is a renewal of our EDRN Biomarker Reference Laboratory (BRL) which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins Medical Laboratories (JHML) at the Johns Hopkins Hospital. The BRL will continue to serve as a network resource for clinical and laboratory validation of biomarkers, which includes technological development and assay refinement. The JHML are certified by the College of American Pathologist (CAP) and regulated by CLIA (Clinical Laboratory Improvement Amendments of 1988). As such, the JHML follow stringent, good laboratory practice (GLP) guidelines for quality control and quality assurance. The proposed product development will be conducted at the Center for Biomarker Discovery and Translation (CBDT) at The Johns Hopkins University. The project goal is to validate serum proteomic biomarkers, including two biomarkers discovered in our current EDRN BRL developmental study, for the prediction of aggressive prostate cancer in men prior to prostate biopsy. The product AGPC is an in vitro diagnostic multivariate index assay (IVDMIA) that combines a panel of biomarkers into a single-valued numerical index score. We have assembled a strong team of research and clinical scientists with many years of experience with cancer biomarkers and in technology development, study design, bioinformatics, validation, and translation. Dr. Chan, the PI, is the Director of both CCD and CBDT. He has over 30 years of experience in clinical chemistry and has conducted many (> 75) research studies funded by industry on cancer diagnostics leading to the approval by the FDA. Since the inception of the EDRN in 2000, five EDRN developed assays have been approved by the FDA for clinical use. Of these five, our BRL led the development of serum OVA1 for ovarian cancer, serum proPSA (phi) for prostate cancer, and served as the reference lab for the urine PCA3 study for prostate cancer. In fact, OVA1 which is based on our original multiplex proteomic study published in Cancer Research, was the first proteomic IVDMIA ever cleared by the FDA for clinical use. In addition, three leading diagnostics/biotechnology companies have agreed to collaborate with us in our product development proposal. In this renewal, we plan to continue our strong commitment to the EDRN mission through network collaborations, and provide leadership in biomarker validation, technology/assay improvement, and product development. With this multi-disciplinary team of scientists, the BRL at Johns Hopkins offers the best opportunity for the success of cancer biomarker validation and translation into the clinic for the early detection of cancer.

Public Health Relevance

As part of the EDRN network, the purpose of this Biomarker Reference Laboratory is to assist in the development and validation of laboratory assays in order to bring new biomarkers for the early detection of cancer from the laboratory to the clinical setting. We propose to develop a new product called AGPC for the prediction of aggressive prostate cancer. This will help to identify those men who will most likely benefit from prostate cancer treatment.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24CA115102-12
Application #
9260815
Study Section
Special Emphasis Panel (ZCA1-RPRB-B (A1))
Program Officer
Sorbara, Lynn R
Project Start
2005-06-20
Project End
2021-03-31
Budget Start
2017-04-01
Budget End
2018-03-31
Support Year
12
Fiscal Year
2017
Total Cost
$437,400
Indirect Cost
$167,400
Name
Johns Hopkins University
Department
Pathology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
Song, Jin; Sokoll, Lori J; Pasay, Jered J et al. (2018) Identification of Serum Biomarker Panels for the Early Detection of Pancreatic Cancer. Cancer Epidemiol Biomarkers Prev :
Li, Qing Kay; Shah, Punit; Tian, Yuan et al. (2017) An integrated proteomic and glycoproteomic approach uncovers differences in glycosylation occupancy from benign and malignant epithelial ovarian tumors. Clin Proteomics 14:16
Tosoian, J J; Patel, H D; Mamawala, M et al. (2017) Longitudinal assessment of urinary PCA3 for predicting prostate cancer grade reclassification in favorable-risk men during active surveillance. Prostate Cancer Prostatic Dis 20:339-342
Loeb, Stacy; Shin, Sanghyuk S; Broyles, Dennis L et al. (2017) Prostate Health Index improves multivariable risk prediction of aggressive prostate cancer. BJU Int 120:61-68
Sanda, Martin G; Feng, Ziding; Howard, David H et al. (2017) Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer. JAMA Oncol 3:1085-1093
Toghi Eshghi, Shadi; Yang, Weiming; Hu, Yingwei et al. (2016) Classification of Tandem Mass Spectra for Identification of N- and O-linked Glycopeptides. Sci Rep 6:37189
Sun, Shisheng; Shah, Punit; Eshghi, Shadi Toghi et al. (2016) Comprehensive analysis of protein glycosylation by solid-phase extraction of N-linked glycans and glycosite-containing peptides. Nat Biotechnol 34:84-8
Yang, Weiming; Jackson, Brooks; Zhang, Hui (2016) Identification of glycoproteins associated with HIV latently infected cells using quantitative glycoproteomics. Proteomics 16:1872-80
Hoofnagle, Andrew N; Whiteaker, Jeffrey R; Carr, Steven A et al. (2016) Recommendations for the Generation, Quantification, Storage, and Handling of Peptides Used for Mass Spectrometry-Based Assays. Clin Chem 62:48-69
Loeb, Stacy; Sanda, Martin G; Broyles, Dennis L et al. (2015) The prostate health index selectively identifies clinically significant prostate cancer. J Urol 193:1163-9

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