EDRN Reference Set Call

Wednesday, January 15, 2025

Present (Attendees at meeting in BOLD):

NCI:  Guillermo Marquez, Richard Mazurchuk, Indu Kohaar, Christos Patriotis, Amanda Skarlupka, Matt Young 

DMCC: Ziding Feng, Jackie Dahlgren, Royce Malnik, Yingye Zheng

GI:

• Colon: MD Anderson: Robert Bresalier (Chair)
• Pancreas: University of Texas MD Anderson: Anirban Maitra
• University of Minnesota: Aasma Shaukat

Lung:

• Vanderbilt: Stephen Deppen (Co-chair)
• Boston University: Marc Lenburg
• Meso Scale Diagnostics: Martin Stengelin
• University of California, Los Angeles: Tran Linh
• University of Maryland: Sandy Stass

Prostate:

• Pacific Northwest National Laboratory: Karin Rodland
• Eastern Virginia Medical School: John Semmes
• Johns Hopkins: Hui Zhang
• University of Michigan: Javed Siddiqui

Breast/GYN:

• Arizona State University: Karen Anderson
• Massachusetts General Hospital: Steven Skates
• Johns Hopkins: Zhen Zhang
• Meso Scale Diagnostics: Martin Stengelin

BRL (All Groups):

• NIST: Hua-Jun He

Current Action Items:

1. DONE: Chris Li/BRS Application: The main reviewer will send Robert Bresalier his comments.
2. Nicole Rich/HEDS Application: Matt Young will follow up with Amit Singal.
3. ONGOING: Yingye Zheng to meet with Statistical Working Group to discuss specimen sets being used for discovery.
4. STATUS UNKNOWN: Matt Young will locate the list of GLNE 010 Stool/DNA that Sandy Stass previously sent and re-distribute to the DMCC and Bob Bresalier. Update: this involved specimens that were sent to Dr. Stass’s lab to test a biomarker for Sandy Markowitz but nothing was done.  Dr. Stass wants to dispose of the specimens, but Robert Bresalier knows someone who would like the specimens, but he wants to know what these specimens are before sending them. Dr. Bresalier will follow up with Matt Young about this.
5. ONGOING: GLNE 010: Robert Bresalier will check with Ziding Feng about the composition of the specimens and deal with unblinding since the specimens are not being used for the study.
6. ONGOING: Bob Bresalier will follow-up with Xianghong (Jasmine) Zhou’s regarding her email about whether 1ml will work for their DCP Rapid 50/50 request:  Robert Bresalier stated that Dr. Zhou is tweaking their assay so that the volume of specimen needed is less because more than 1 mL is too much. Dr. Bresalier will follow up with her. 

Discussion:

Review of Applications: 

• Chris Li/BRS: Reviewer: The sample size request is too small. The MSD platform is excellent. Developing assays for their markers.  Concerned that level of evidence is low—for each cancer detected from markers, how many are false positives? 80% specificity means 1/5 of the women would get a false positive—would the women get an extra mammogram? Are there sufficient numbers to look at the sensitivity and specificity to get a good assessment of the operating characteristics that have clinical implications here. Not enough information to make a decision. The reviewer will send Robert Bresalier his comments. Another comment was whether the concentration in the samples would match the concentration on the MSD platform with the amount of specimen requested. The clinical criteria will get them where they want to get to, the issue is that it is a search of combination of 4 markers from 7 markers and they will need a cohort of specimens of cases and controls to do this on the MSD multiplex platform. Also not sure how many markers will be tested on MSD, and what is the volume required to run on this platform. What is the plan for the 200 ul they are requesting?
• Nicole Rich/HEDS: Wants to look at the association between sex-related biologic factors and HCC risk among cirrhosis patients in the HEDS cohort. Seen as discovery—can she review data instead of using biospecimens? Not sure what will be done with the data, or the clinical impact. Haven’t received any reviews from Amit Singal or the liver group. Table and ask for comments from the PI and other reviewers. Matt Young will follow up with Amit Singal.

Scientific Workshop: Robert Bresalier suggested that the group submit a poster showing the number of applications that have been reviewed by this group? Dr. Bresalier is chairing a session on Thursday, March 6th “Clinical utility trials: Clinical utility assessment with focus on the efforts of the Cancer Screening Network, including both MCEDs and single cancer biomarkers.” This session has presenters from industry and the regulatory space. 

Next Call: Wednesday, February 5th at 8 a.m. Pacific/11 a.m. Eastern.