EDRN NCI-DMCC Monthly Conference Call Agenda

Thursday, October 13, 2022

3 p.m. ET

Zoom Link: https://zoom.us/j/97025281491

Meeting ID: 97025281491

Approval of Minutes from September 8, 2022, call. The action items from that call were:

NCI Updates/Paper Reduction: The DMCC will work with the PIs to make sure they are able to access this information on the website.

Reference Sets:

NCI Updates

DMCC Updates

Update on Fred Hutch Core Funds:

White Paper Updates

Validation Studies/Collaborations/Team Projects

GLNE 007: Recruitment Goal: 1200 participants (prospective): Current Recruitment: 771 Confirmed; 71 Consented and expected to be confirmed. There are 100 confirmed Cancers and 15 cancers consented and expected to be confirmed. Several manuscripts are in process.

GLNE-010: Prevalence paper has been accepted.

HEDS: Recruitment: Goal: 1550 participants (prospective): Current Recruitment: 1723 Confirmed; 0 Pending. 31 DCP participants enrolled in HEDS. 110 HCC. There are 4 papers in process.

Panc Cyst Reference Set: Recruitment Goal: 450 participants (prospective): Current Recruitment: 470 Confirmed; 0 Pending. Closed. Leadership is working on a summary of the reference set so that it can be advertised for use. Have 1 application to use this reference set.

New Onset Diabetes (NOD): Recruitment Goal: 10,000 participants (prospective). Closed to accrual as of end of business day 5/27/2022. Current Recruitment as of 10/10/2022 is 2,271 Confirmed; 72 consented as part of EDI and not included in 2,271.

Pancreatic Prediagnostic Imaging Repository: Retrospective Recruitment: 1200 Pre-diagnostic cases and 1200 controls at a minimum. The current recruitment is about 1000 pre-diagnostic cases and 1000 controls. Waiting to finalize the numbers from JHMI, Stanford, and DFCI to get across our minimum number. Plan to use cases and controls for the projects proposed, but they are not available for the public yet. Once we are ready to publish the initial findings, the cases and controls will be made available to the wider scientific community. finalized the MTA and IRB issues with Dana Farber and anticipate a large data transfer in the coming week or two.

LTP2: Recruitment Goal: 100 Cases/100 Controls (prospective): Current Recruitment: 345 Confirmed; 20 Pending. Recruitment is completed. LTP2 working with sites to get their follow-up data entered, adjudication complete, specimens shipped, and images uploaded to JPL. Next steps will be to select samples for analysis at the various laboratories.

Prostate MRI: Recruitment Goal: 1500 participants (prospective).  Current Recruitment: 340 Confirmed; 0 Pending. Arul Chinnaiyan’s lab is running the assays for the interim analysis: he has received the first ½ of the specimens. The other ½ are being shipped to FNLCR, and this is almost  complete. After these specimens have arrived at FNLCR, they too will be selected and sent to Dr. Chinnaiyan. Once biomarker results returned to DMCC then DMCC will conduct the interim analysis which will drive the next steps.  Need to add CPDR to the Collaboration Agreement when done so that tissue can go to the repository.

URS: Recruitment Goal: 240 participants with Post-DRE Urine (prospective).  Current Recruitment: 230 confirmed for Round 2 Post-DRE Urine; 28 pending for Round 2 Post DRE Urine. URS working with Weill Cornell Central Review to finish up their reviews. DMCC entered the central review data that they received in VSIMS because Weill Cornell does not have staff to do this. UCLA is finished running whole genome wide analysis—DMCC is expected to get all data soon.

Canary PASS: Recruitment Goal: Open Ended (prospective). Current Recruitment: 2171 confirmed; 9 pending. 900 progression events since diagnosis and 854 since baseline.

BBD: Retrospective Selection: 270 BBD/90 Invasive. Current Numbers: 324 Total: 199 BBD; 18 DCIS; 1 LCIS; 106 Cases. There is no more selection. DMCC presented preliminary analysis of Dr. Godwin’s use of the BBD set to the study group.  More analysis is being done.

Breast Imaging (BRSI): Recruitment Goal: 1050 participants (prospective) and 1000 retrospective selection. Current Recruitment: 971 confirmed (prospective); 798 (retrospective). 6 Pending. Working on analyzing imaging data. Uploading images to LabCAS. Cleaning up data.

Uterine Lavage (UL): Recruitment Goal: 250 participants (prospective).

Current Recruitment: 180 Total Confirmed—of these:

-- Cohort 1 No OVCA: 97

-- Cohort 1 OVCA: 38

-- Cohort 2 RSSO: 45

-- Pending: 10

Outstanding Reference Set Summary

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The minutes from the last call on September 8th are below:

EDRN NCI DMCC Monthly Call Minutes

Thursday, September 8, 2022

Present:

NCI:       Natalie Abrams, Felicia Evans Long, Karl Krueger, Guillermo Marquez,  Christos Patriotis, Jo Ann Rinaudo, Lynn Sorbara, Juan Miguel Villanueva, Paul Wagner, Matt Young

DMCC:  Ziding Feng, Jackie Dahlgren, Royce Malnik

Action Items from September 8, 2022:

DONE: NCI Updates/Summaries of Grant Information for BCCs and CVCs to DMCC: Guillermo Marquez will compile information such as research summaries and personnel (but not budget information) for each of the BCCs (BRLs and BDLs) and the CVCs and send them to the DMCC.

NCI Updates/Paper Reduction: The DMCC will work with the PIs to make sure they are able to access this information on the website.

DONE: Election of Chairs, Co-chairs of EDRN Steering Committee: DMCC will send a reminder to the PIs and MPIs to nominate chairs and co-chairs.

Reference Sets:

Discussion:

Minutes from August 11, 2022: Minutes approved.

NCI Updates:

EDRN Steering Committee Meeting: RM sent a survey out.

Election of Chairs, Co-chairs of EDRN Steering Committee: DMCC will send a reminder to the PIs and MPIs to nominate chairs and co-chairs. PIs who have an Interagency Agreement do not vote.

Statistical Working Group: Ziding Feng said that he got a good response to his request for statisticians from other EDRN sites to join this working group.  He asked if members of the group will participate in analyzing data—he believes that it is the DMCC’s responsibility to analyze the data.  He added that if the other members of the group participate in study design and analysis strategy they can be a co-author of the paper.  The other sites don’t have this in their RFAs and there could be a conflict of interest. The participation of the members is voluntarily and that they are not expected to perform analysis.

Sending Research Summaries of each BCC and CVCs to the DMCC: Guillermo Marquez will compile information such as research summaries and personnel (but not budget information) for each of the BCCs (BRLs and BDLs) and the CVCs and send them to the DMCC.

Paper Reduction: The DMCC has been tasked by NCI to no longer provide PDF documents or call-in information that are sent via email or included in calendar invites for meetings such as Collaborative Group meetings. This information will be on the EDRN Website (Public Portal).  The DMCC will work with the PIs to make sure they are able to access this information on the website.

Mailing Lists: All the mailing lists will need to be updated with the new members and the non-continuing PIs will be removed unless they have a CDA for this grant cycle.

Clinical Utility Trials: The DMCC needs copies of the 3-page Clinical Utility Trial proposals. The Letter of Intent/Pre-proposal for these are due September 30th.   The LOIs will be reviewed in October.

Core Funds Update:

On August 18th 2022, the current NOA for EDRN was amended with a new end date of 8/31/2022.  The three projects who requested a no-cost extension were notified that their Core Fund subaward would need to be revised with the new end date.

Robin Leach/The University of Texas Health Science Center: Amended subaward agreement fully execute on 8/25/22. No invoice activity submitted yet. Balance $59,068

Thomas Pisanic/Johns Hopkins University: Revised subaward agreement sent to JHU on 8/19/22 for review and signature. Currently pending their signature of the subaward agreement. Follow up email sent to JHU on 9/2/22. Balance $36,913.04.

Eric Grogan/Vanderbilt University: Revised subaward agreement sent to VUMC on 8/19/22 for review and signature. Currently pending their signature of the subaward agreement.  Follow up email sent to VUMC on 9/2/22 for a status update. Balance $70,538

Communication with FNLCR: Jackie Dahlgren reported that there are still issues with communicating with Norma Diaz Mayoral but that is has improved.

Updates on Ongoing Studies: Jackie Dahlgren asked about which studies from the last cycle will be approved to continue into this cycle.  For the GLNE007 study, she has been asked to begin implementing the single IRB process, and she needed to know if she could proceed on this.  Christos Patriotis said that the DMCC is only the IRB of record for studies that are approved post-award, not studies in the PIs grant application.  The GLNE007 can be grandfathered so that it doesn’t need sIRB.

Previous Action Items from July 14, 2022:

DONE: NCI Updates/Site Visit/Core Funds/Set-aside Funds: Ziding Feng will draft an updated policy for releasing set-aside funds.

Reference Sets:

Next Call:  Thursday, October 13th at 3 p.m. Eastern/Noon Pacific.