Validation of plasma biomarker panels for the early detection of pancreatic cancer
Principal Investigator
Name
Brian Haab
Degrees
PhD
Institution
Van Andel Institute
Position Title
Professor
Email
About this CDAS Project
Study
PLCO
(Learn more about this study)
Project ID
2021-0017
Initial CDAS Request Approval
Jul 21, 2021
Title
Validation of plasma biomarker panels for the early detection of pancreatic cancer
Summary
A collaborative group within the Early Detection Research Network (EDRN) is focused on developing plasma biomarkers for the early detection of pancreatic ductal adenocarcinoma (PDAC). The group consists of five clinical sites and experimental sites and is supported by a network-wide data coordinating and biostatistics site. Earlier discovery research resulted in the identification of several promising candidates. In an effort to identify the best candidates and to investigate the value of combining biomarkers from different sites, the collaborative group performed two consecutive collaborative studies. In each study, a common sample set was sent blinded to each of the labs; the labs ran their own assays and sent case/control calls to the network biostatistician; and the performance of the individual and combined panels were evaluated. These rigorous studies resulted in the identification of lead panels from study 1 that were validated in study 2 to outperform CA19-9 using the blinded calls. Thus, these biomarker panels already have passed a stringent level of validation.
The next step is to test their performance in samples that were collected prior to the diagnosis of PDAC. Certain samples within the PLCO collection would be ideal for this purpose. Our goal is to test our lead biomarker panels on samples that were collected within 0-3 years of the diagnosis of PDAC, along with matched controls. Such a study would allow us to gain invaluable information on the potential of our lead candidates to be used as part of surveillance programs for PDAC.
We will test 3 panels. Each one consists of CA19-9 with the consecutive addition of 1, 2, or 3 more markers. Thus, they are 2-marker, 3-marker, and 4-marker panels, with each panel identical to the previous but with one additional marker. A total of 4 individual assays are needed, inclusive of CA19-9.
The next step is to test their performance in samples that were collected prior to the diagnosis of PDAC. Certain samples within the PLCO collection would be ideal for this purpose. Our goal is to test our lead biomarker panels on samples that were collected within 0-3 years of the diagnosis of PDAC, along with matched controls. Such a study would allow us to gain invaluable information on the potential of our lead candidates to be used as part of surveillance programs for PDAC.
We will test 3 panels. Each one consists of CA19-9 with the consecutive addition of 1, 2, or 3 more markers. Thus, they are 2-marker, 3-marker, and 4-marker panels, with each panel identical to the previous but with one additional marker. A total of 4 individual assays are needed, inclusive of CA19-9.
Aims
1. Acquire data on blinded specimens for the candidate biomarkers
2. Make case/control calls on the samples using classification rules with predefined cutoffs
3. Send the measured biomarker values as well as the binary calls to the study biostatistician and evaluate performance relative to predetermined performance targets.
Collaborators
Brian Haab (Van Andel Institute)
Randall Brand (University of Pittsburgh Medical Center)
Anirban Maitra (MD Anderson Cancer Center)
Ying Huang (Fred Hutchinson Cancer Research Center)
Anna Lokshin (University of Pittsburgh Medical Center)
Brenda Diergaarde (University of Pittsburgh Medical Center)
Suriinder Batra (University of Nebraska Medical Center)