Spring/Summer 2019 NAACCR Narrative Leave a comment


Castine Clerkin, MS, CTR
NAACCR Program Manager of Virtual Pooled Registry
cclerkin@naaccr.org

 

 

Hello and Happy Summer! Over the last few months, I’ve received some inquiries about the status of the Virtual Pooled Registry project and the pilot testing that has been initiated. In an effort to share my responses as broadly as possible, this article includes list of pertinent questions and answers.

 

What is the status of the Virtual Pooled Registry Cancer Linkage System (VPR-CLS)?

The VPR-CLS is being developed in two phases that align with distinct, but inter-related, aspects of the linkage process:

  • Phase I supports secure, standardized multi-registry linkages and release of aggregate match counts (by state and diagnosis year) to the researcher. Phase I includes a web-based researcher application, secure transfer of files between researchers, IMS and registries, and linkage behind each registry firewall using Match*Pro and a standard configuration file. Phase I functionality is currently being pilot tested with four cohort studies.
  • Phase II supports a streamlined process of applying for release of individual-level cancer data on matched cases identified in Phase I. When complete, it will include use of a web-based Templated IRB/Registry Application, a dedicated Central IRB to review minimal risk linkage studies, and a robust and comprehensive tracking system. Phase II development and testing is anticipated to be complete by the end of 2019.

 

What studies are collaborating on the VPR-CLS pilot testing in 2019?

Many study investigators expressed interest in testing the VPR-CLS. Information on each study was reviewed and we selected the studies listed below:

Studies for Phase I: Linkage and release of match counts

  • Cohort Cancer Registry Follow-Up Study, which includes participants from Nurses’ Health Study and Health Professional Study (Harvard Medical School): Cohort of 290K female nurses and male health professionals.
  • Transplant Cancer Match Study (NCI Division of Cancer Epi and Genetics): Cohort of 1.5M organ transplant recipients, candidates, and donors.
  • Sister Study (National Institute of Environmental Sciences): Cohort of 50K sisters of women diagnosed with breast cancer.
  • High School and Beyond (University of WI and University of MN): Nationally representative sample of 27K high school students.

Studies continuing to Phase II: Request for individual-level data on matched cases

  • Childhood Cancer Survivors Study (St. Jude Children’s Hospital): Phase I completed in fall 2018. Cohort of 36K children diagnosed with cancer.
  • Transplant Cancer Match Study

 

How many registries are participating in the VPR-CLS pilot testing?

Thirty-eight U.S. cancer registries have graciously volunteered to participate in the pilot testing. In this role they will interface with the VPR-CLS, perform the Phase I linkages, upload match count reports, provide feedback on the system and the linkage process, and navigate the approval process for those studies proceeding to Phase II.

 

Is the Templated IRB/Registry Application  part of the Phase II pilot testing?

Yes, the Templated IRB/Registry Application (TIRA) will be incorporated into the Phase II pilot testing. The TIRA was developed as a common application that could be used in lieu of state-specific applications for the registry or IRB.  While the TIRA is optional resource, we encourage registries/IRBs to utilize this form in an effort to minimize the number of different applications that a study must complete when requesting individual-level data on the matched cases. Currently, 73% of the pilot test registries are able to use the TIRA for all aspects of their process.

 

Is the Central IRB part of the Phase II pilot testing?

No, the Central IRB, a contract funded and coordinated by NCI, is not yet established and will not be part of the pilot testing. The Central IRB is intended to serve as the reviewing body for multi-site studies in accordance with changes in the Common Rule (effective 1/20/20), thereby reducing the administrative burden of duplicative local/state IRB reviews for minimal risk linkage studies. Once established, the Central IRB will be an optional resource for VPR participants.

 

Is use of the Templated IRB/Registry Application or the Central IRB a requirement for participation in VPR linkage studies?

No, any registry can participate in VPR linkages. Use of the Templated IRB/Registry Application and the Central IRB is optional and does not impact a registry’s ability to participate in the VPR.

 

Is the ATSDR Camp Lejeune Study part of the VPR-CLS pilot testing occurring in 2019?

No, the ATSDR Camp Lejeune Study is not a designated VPR-CLS pilot test study. However, the Camp Lejeune Study is a separately funded initiative that will use the VPR-CLS infrastructure when the linkage is performed in early-2020.

 

As always, please contact me if you have any comments or questions!

 

 

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