A Biomarker Bakeoff in Early Stage Pancreatic Cancer

Abbreviated Name
PaCa Bake Off 1
Lead Investigator
Haab, Brian — Van Andel Research Institute
Coordinating Investigator
Zheng, Yingye — Fred Hutchinson Cancer Center
Involved Investigators

Abstract

The gastrointestinal collaborative group within the EDRN is in an optimal position to carry out such a study given its shared resources and interactive structure. In this project, the two pancreatic CVCs in the EDRN will provide samples to be distributed to four laboratories with promising biomarkers. The laboratories will run their own assays and perform initial analyses on the blinded PDAC and control samples. Our biostatistical collaborator, Dr. Huang at FHCRC, will perform the statistical evaluations. Biomarkers meeting the predetermined performance criteria will move forward to further validation using the EDRN reference set. In addition, we will determine whether any novel combinations of biomarkers should be further tested.

Aims

Specific Aim 1: Compare the performance of several candidate biomarkers for discriminating resectable PDAC from benign pancreatic disease both alone and in combination with CA19. Specific Aim 2: Test the value of novel combinations of biomarkers to identify candidates for further testing using the reference set.

Analytic Method

Once the composition of the sample set is finalized by the two CVCs, aliquots of the samples will be transferred to each of the four laboratories running the biomarker experiments. Each site will run its own biomarker assays and perform initial data processing. Based on rules that will be predetermined, each site will make classifications of each sample as a case or control. The calls and data will be sent to Dr. Huang at FHCRC. Dr. Huang will have access to the diagnoses associated with the samples, from which she will determine the performance of the candidate biomarkers and make statistical comparisons among them and CA19-9. CA19-9 measurements will be provided by the laboratories of Drs. Haab and Batra. Information on each of the candidate biomarkers is provided in the following sections.

Outcome

Previous research in EDRN laboratories and elsewhere has produced several candidate biomarker(s) for the detection of early-stage pancreatic ductal adenocarcinoma (PDAC), many of which show promise for significantly improving upon the performance of the current best marker, CA19-9. As yet, the relative performance of the markers in combination is not known because a rigorous comparison using a common sample set has not been performed. A direct comparison of the potential biomarkers in a comparative study (“biomarker bakeoff”) would enable an objective determination of which candidates should move forward for further validation, as well as an assessment of the potential value of using novel combinations of the biomarkers. The gastrointestinal collaborative group within the EDRN is in an optimal position to carry out such a study given its shared resources and interactive structure. In this project, the two pancreatic CVCs in the EDRN will provide samples to be distributed to four laboratories with promising biomarkers. The laboratories will run their own assays and perform initial analyses on the blinded PDAC and control samples. Our biostatistical collaborator, Dr. Huang at FHCRC, will perform the statistical evaluations. Biomarkers meeting the predetermined performance criteria will move forward to further validation using the EDRN reference set. In addition, we will determine whether any novel combinations of biomarkers should be further tested.

Publications

Biomarkers

Data Collections

  • No data collections available at this time for this protocol.
 Team Project
Start Date
May 1 2017
Estimated Finish Date
Apr 30 2018
Finish Date
Nov 1 2024
Protocol ID
421
Protocol Type
Collaboration
Fields of Research
  • Proteomics
Collaborative Group
G.I. and Other Associated Cancers Research Group
Cancer Types
  • Malignant neoplasm of pancreas
Phased Status
1

Associated Forms