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Validation of Early Detection Ovarian Cancer Biomarkers (Team Project)

Skates, StevenMassachusetts General Hospital

No involved investigator sites defined.

Potential Proteins (Gene Name) BCAM, AGRN, ANXA2, IGFBP2, GRN, DSG2, A1P6AP2, FBLN1, FOLR1, LIBP1, NPC2, PROS1, SEC1M1, CIGF, DKK3, IGFBP3, LRG1, PLIP, CD248, CD59, CPA4, CST6, DAG1, DSC2, ECM1, EFEMP1, FSTL1, HSPG2, HTRA1, MXRA5, PCOLCE, SERPINA6, TAGLN2;CCDC19, GLOD4, GM2A, PLEC1, PSAP, QSCN6, NUCB1. Potential Proteins (Accession) P30086, P40305, P03973, O43291, Q12889, Q96910, P16422, P19957, P01024, Q9BXX0, P04275, Q9UBY5, O43194, Q86V14, P02760
Breast and Gynecologic Cancers Research

Early detection of Ovarian Cancer (OC) is one of the key clinical problems in this disease. We propose a team EDRN project to address the issue of early detection of OC by performing a validation study on candidate protein markers already identified in previous EDRN research or in the literature (e.g. protein products of TCGA identified mutations specific to ovarian cancer). (See appendix for full listing) Biospecimen sources have been identified which include samples obtained at diagnosis and matched controls (Urban, Godwin, Marks, Skates), and longitudinal samples obtained prior to diagnosis (Urban, Skates, Godwin). Bioinformatic filters will be applied to rank the candidates (Diamandis). In order of ranking, candidate proteins for which high quality antibodies are available will be measured by development of ELISAs at JHU (Chan/Zhang) or through NAPPA at DFCI (Anderson/LaBaer), while for other candidates mass spectrometry based selective reaction monitoring (SRM) assays will be developed at PNNL (Rodland). Three milestones are defined. The first two milestones are to assemble the necessary specimens and to develop the qualifying assay(s). The final milestone is to estimate the markers’ sensitivity one year prior to diagnosis at a given high specificity.

1. Rank candidates identified through past research using bioinformatic analyses (GO, KEGG, Ingenuity), including cancer pathway analyses and gene ontology classifications. 2. Attempt to develop assays for top ranked candidates from step 1 with goal of assay development for 50 candidates (using multiplex immunoassays where high quality mAb pairs or mAb/pAb pairs exist, and SRM targeted mass spec for all other candidates) 3. “Rule in” at least 10 and at most 25 candidates based on assay performance in serum biospecimens obtained at diagnosis, achieving minimal clinical sensitivity (> 5%) at 98% specificity. 4. Measure in pooled samples most proximal to diagnosis of ovarian cancer case in screening study, and in matched control samples, minimizing pooling to achieve minimum required volume for SRM in depleted serum. 5. Rank candidates by sensitivity at fixed high specificity 6. Measure up to top 25 candidates from step 5 in individual longitudinal samples from ovarian cancer cases in screening study, and in matched control samples 7. Candidates validated for early detection of ovarian cancer if clinical sensitivity achieved (5% or greater) at 98% specificity at least 1 year prior to clinical detection.
ELISAs, NAPPA and mass spectrometry based selective reaction monitoring (SRM)

No datasets are currently associated with this protocol.

New Funding Opportunity: Biomarker Development Laboratories for the Early Detection Network: Applications Due May 23

Update: Pre-application webinar information now available.

The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.

The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.