Updates for the Data Management & Coordinating Center

The Data Management & Coordinating Center has released updates on September 5, 2018. The update includes information from Ziding Feng, PhD, Mark Thornquist, PhD, Margaret Pepe, PhD, and Jackie Dahlgren, MS. Stay informed with the latest developments in data management and coordination.

• Data management
• Coordinating center
• Updates
• Ziding Feng
• Margaret Pepe

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1. Updates for the Data Management & Coordinating Center Ziding Feng, PhD, Mark Thornquist, PhD, Margaret Pepe, PhD, Jackie Dahlgren, MS September 5, 2018,

2. EDRN Mission Conduct successful validation studies and move biomarkers from lab to clinics.

3. DMCC Responsibilities Network coordination. Data management and protocol development Theoretical and applied statistical research (no longer in this RFA) Validation information system and services Core funds management (added in this RFA)

4. Highlights of DMCC Achievements Validation studies: Supporting 9 ongoing prospective multi-center studies (lung(2), prostate(2), GI(3), breast/gyn(2)) plus NOD. Construct and maintain 11 Clinical Reference Set (lung, prostate(2), breast(3), pancreatic, liver, bladder, colon, cancer in women), and coordinate their uses and data analyses.

5. Major Accomplishment in this funding cycle (completed validation studies since 2016) Sanda/Wei prostate (PCA3 & T2-erg, JAMA- Oncology) EDRN needs more of such studies

6. Reference Set Lung (retrospective & prospective) Prostate (retrospective & prospective) Breast (retrospective & prospective) Pancreas (retrospective & prospective) Liver (retrospective & prospective) Bladder (prospective) Colon (retrospective) Ovarian (managing an existing set)

7. Other Grants Built upon EDRN Work PROSPR Coordinating Center (Li/Barlow/Zheng). 2018-2023. CPDPC Coordinating Center (Feng/Maitra -2018, Yuan/Li/Maitra 2018-2020) Liver Cancer Early Detection Consortium DMCC (Feng, 2018- 2023)

8. EDRN/DMCC Coordination for Network Collaborative Studies

9. DMCC: Study Operations Overview

10. DMCC: Study Operations Overview

11. DMCC: Study Operations Overview

12. Use of Reference Sets

13. DMCC Coordination Levels Category A Category B Category C Category D Prospective/Multi-Center Retrospective Specimen Repositories Statistical Consultation Study Name New Collection Data Harmonization No Limit No Limit Maximum 6 Maximum 4 X Breast Ref X DCP & Liver Ref X Lung Ref X Pancreatic Ref X Prostate Ref X Colon Ref X Cancer in Women Ref X MSA & Bladder Ref X PCA3 & Prostate Ref Benign Breast Disease (BBD) X DCIS X X 1 HEDS Liver X 2 Pancreatic Cyst Ref X 3 Lung Nodule LTP2 4 URS Prostate X 5 Chile-US Mesothelioma X 6 GLNE 010 Colon X *7 Breast Ref Set Imaging BRS-I X X *8 Uterine Lavage X *9 Prostate-MRI X *10 NOD X *Funded through carry-forward or supplement

14. Ongoing Prospective Study Facts (as of 7/31/2018) Number of participants Confirmed Ineligible 1,521 155 395 173 184 18 249 29 42 5,282 129 407 27 Number of Recruiting Sites Number of Coordinator Trainings Number of Data Clarifications Number of Specimens collected Number of Site Visits Number of Inquiries Number of Requests Protocol Name 1 HEDS Liver 7 14 20 792 188 72 85,337 2 Pancreatic Cyst Ref 14 20 27 363 88 40 31,106 3 Lung Nodule LTP2 8 12 13 95 103 9 7,418 4 URS Prostate 12 19 10 375 102 16 9,729 5 Chile-US Mesothlioma 1 4 2 1 5 2 748 32 (old) 43 30 2,140 969 32 379,826 6 GLNE 010 Colon 8 (new) 12 2 77 47 1 29,450 7 Breast Ref Set Imaging BRS-I 2 2 0 6 14 0 40 TBD 8 Uterine Lavage 9 Prostate-MRI 5 TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD Totals 47 126 104 3849 1516 172 2806 543614 Types of Inquiries: Protocol Questions SOP Questions Specific Participant Questions Types of Requests: Incomplete Specimen Worksheets Specific Participant Questions Data Updates Supply Requests & Questions Entry Errors

15. How can DMCC help you? Consultations for sites on study design, biomarker development and triage strategies, data analyses, challenges that require statistical innovations. The DMCC statistical team is arguably the best in developing new statistical methodology in diagnostic/screening biomarker evaluations. When you think you may have a biomarker that is near the stage of validation study, talk to DMCC to help you appraise your data evidence, help you write validation study proposal to be submitted to EDRN EC for review/approval. It does not have to be your own biomarker! Validation study: closely work with NCI and DMCC as a team.

16. Questions?