Early Diagnosis

Reporter: Stephen J. Williams, Ph.D.

This post contains a curation of all Early Diagnosis posts on this site as well as a curation of the Early Detection Research Network.

Early Research Detection Network (EDRN)

Welcome to EDRN

The Early Detection Research Network (EDRN), an initiative of the National Cancer Institute (NCI), brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk.

Getting Started…

Check out the EDRN Highlights — a listing of our accomplishments and milestones.

 

► Scientific Components	► For Public, Patients, Advocates
► Collaborative Opportunities (how to join EDRN)	► For Researchers

Highlights

Highlights of the accomplishments of the Early Detection Research Network.

A brief list of major EDRN-developed assays that have been adapted for clinical use is described in the table below:

Detection/Biomarker Assay	Discovery	Refine/Adapt for Clin Use	Clinical Validation	Clinical Translation
Blood proPSA		✓	✓	FDA approved
Urine PCA3		✓	✓	FDA approved
OVA1™ for Ovarian Cancer		✓	✓	FDA approved
ROMA Algorithm for CA125 and HE4 Tests for Pelvic Mass Malignancies		✓	✓	FDA approved
Blood/DCP and AFP-L3 for Hepatocellular Carcinoma		✓	✓	FDA approved
Blood GP73	✓	✓	✓	Together with AFP-L3 used  for monitoring cirrhotic patients for HCC in China
MiPS (Mi Prostate Score Urine test), Multiplex analysis of T2-ERG gene fusion, PCA3 and serum PSA	✓	✓	✓	In CLIA Lab
FISH to detect T2S:Erg fusion for Prostate Cancer	✓	✓	✓	In CLIA Lab
GSTP1 methylation for repeat biopsies in prostate cancer		✓	✓	In CLIA Lab
Mitochondrial deletion for detection of prostate cancer				In CLIA Lab
Somalogic 12-marker panel for Lung Cancer		✓	✓	In CLIA Lab
80-gene panel for Lung Cancer		✓	✓	In CLIA Lab
Vimentin Methylation Marker for Colon Cancer		✓	✓	In CLIA Lab
Galectin-3 ligand for detection of adenomas and colon cancer				In CLIA Lab
8-gene panel for Barrett’s Esophagus		✓	✓	In CLIA Lab
SOPs for Blood (Serum, Plasma), Urine, Stool		✓	✓	Frequently used by biomarker research community
EDRN Pre/Validation Specimen Reference Sets (specimens from well characterized and matched cases and controls from specific disease spectra)		✓	✓	Frequently used by biomarker research community

Since its inception in 1999 EDRN has achieved several key milestones, summarized below:

1998 through 2000: Inception and Inauguration of EDRN

2001 to 2003: Meeting the Challenges to Harness and Share Emerging Scientific Knowledge

• EDRN Second Report, Translational Research to Identify Early Cancer and Cancer Risk, October 2002, http://edrn.nci.nih.gov/docs.) published.
• EDRN joined the Gordon Research Conferences to co-host the New Frontiers in Cancer detection and Diagnosis in 2002.

 

• Guidelines Set for Studies Measuring Biomarker Predictive Power Journal of National Cancer Institute (Vol. 93, No. 14, July 18, 2001).
• EDRN Associate Membership Program Initiated: This novel approach to make EDRN inclusive has been extremely successful. EDRN has now more than 120 Associate Members who are significantly contributing to EDRN efforts in biomarker discovery, development and validation.

2003 to 2004: Network Surges Ahead in Real-time

• Collaborative Discovery and Validation Projects:  More than 100 collaborative projects spanned the various organ sites. These projects are monitored through the EDRN’s electronic System Information System (eSIS).
• EDRN Virtual Specimen Bank and Validation Management System Launched: The EDRN Virtual Specimen Bank, also known as ERNE knowledge system, was deployed to 10 institutions in early 2003, allowing a common web-based query to search for available specimens across the EDRN Clinical Epidemiology and Validation Centers https://ginger.fhcrc.org/edrn/imp/GateServlet?pwd. VSIMS was created to allow multiple studies to be administered efficiently by minimizing development time with standardization of information and data management across multiple activities and research sites. This system encompasses all the security features of Food and Drug Administration (FDA)-required auditing systems.
• Partnership on the Plasma Proteome Project (PPP) Initiative of the Human Proteome Organization (HUPO): PPP project was initiated to evaluate multiple technology platforms, develop bioinformatic tools and standards for protein identification, and create a database of the plasma proteome. The entire study was published in the August issue of the journal Proteomics August 2005, Volume 4 (4), pp 1045-1450.

2005 to 2008: An Investment in Prevention

• In late 2006, EDRN’s Program for Rapid, Independent Diagnostic Evaluation (PRIDE), was established (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-07-003.html ) as an administrative means to assist extramural investigators in successfully conducting cross-laboratory validation of biomarkers. Ten applications have been reviewed and five are being supported.
• EDRN underwent external reviews in 2007 and 2008.
• The Canary Foundation, Palo Alto, CA signed a Memorandum of Understanding with EDRN, NCI on supporting prostate cancer surveillance network of investigators from seven institutions. The tissue and serum will be collected during a three-year period and will be made available to extramural scientists for discovery and validation research.
• The Lustgarten Foundation, N.Y., funded 6 institutions to generate monoclonal antibodies and associated hybridoma cell lines for pancreatic cancer antigens (biomarkers) identified by EDRN and non-EDRN investigators. These resources will be stored at the NCI-Frederick Facility for distribution to extramural investigators.

2009 to 2011: Realizing Investment for Clinical Use

• Two biomarker tests approved by FDA and two IVDs pending FDA review.
• Six biomarker tests offered by CLIA labs.
• One biomarker test approved for clinical use outside the USA

A Curation of Posts on Early Detection of Cancer and Other Early Detection Networks is Included Below

 

BRCA 1 and 2 and Early Detection of Cancer

Early Detection of Prostate Cancer: American Urological Association (AUA) Guideline

Mechanism involved in Breast Cancer Cell Growth: Function in Early Detection & Treatment

Warning signs may lead to better early detection of ovarian cancer

Cancer Detection

Biomarker tool development for Early Diagnosis of Pancreatic Cancer: Van Andel Institute and Emory University

China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality per 4/2014 Lancet Oncology article