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Consortia: A Tool for Interdisciplinary Research in Cancer Genetic Epidemiology

Consortia: A Tool for Interdisciplinary Research in Cancer Genetic Epidemiology Daniela Seminara, Ph.D., MPH EGRP. Desirable Characteristics of Interdisciplinary Consortia in Cancer Genetic Epidemiology.

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Consortia: A Tool for Interdisciplinary Research in Cancer Genetic Epidemiology

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  1. Consortia: A Tool for Interdisciplinary Research in Cancer Genetic Epidemiology Daniela Seminara, Ph.D., MPH EGRP

  2. Desirable Characteristics of Interdisciplinary Consortia in Cancer Genetic Epidemiology • Large studies with interdisciplinary teams working at solving complex scientific problems and responding to an obvious opportunity to advance scientific discovery and its applications • Intensely collaborative • Common Protocol and Methods • Coordinated Parallel and Pooled Analyses • Development of a resource for testing hypotheses from entire research community • Exchange of concepts, approaches and intellectual discourse produces results beyond these possible with single-discipline approaches

  3. Why Consortia in Cancer Genetic Epidemiology? A Consortium can support the study of: • Interactions with environmental exposures • Complex multigenic effects • Gene discovery • Etiologic heterogeneity for tumor subgroups • Prognostic factors A Consortium can facilitate: • Rapid replication of findings. • Pooling of data to increase sample size. • New large-scale efforts.

  4. Where are Epidemiologic Consortia on the NIH Roadmap? • Interdisciplinary Research Implementation Group▪ Interdisciplinary Research (IR) Centers.Planning grants will be awarded to begin IR programs that will address significant and complex biomedical problems, particularly those that have been resistant to more traditional approaches. Planning activities will include approaches to overcoming traditional institutional barriers to IR, which are intended to lay the foundation and prepare investigators for submitting a subsequent application for support through an IR Consortium. (NIH website)

  5. EGRP $ In Consortia (in Millions)

  6. EGRP- Supported Epidemiology Consortia: Flexibility of Design Cohorts Consortium Translational Clinical Genetics Screening/prevention/treatment Gene discovery Gene characterization GxG and GxE Breast and Colon CFRs (hybrid design) Case-Control Consortia Familial Consortia

  7. Design-Based Consortia • Cohorts: • multiple outcomes • converging mechanisms • Case-control: • less common tumors • specialized components • Family-based: • high and intermediate penetrance genes • environmental modifiers

  8. Prostate Lung Melanoma Breast Colon Chronic Lymphocytic Leukemia Multiple Myeloma Brain Lymphoma Bladder Esophagus Head and Neck Pancreas Ovarian Endometrial Others… Existing or Developing Consortia by Cancer Site (1996-2005)

  9. Characteristics of Consortia in Cancer Genetic Epidemiology • Retrospective and/or prospective data • Based on cancer site or research theme • Initially formed by investigators or solicited by funded agency • Support for infrastructure and/or for research project (s) • Different levels of data and biospecimen sharing • Centralized or de-centralized molecular technologies

  10. How does the Epidemiology and Genetics Research Program (EGRP) Foster Consortia? • Identify research priorities • Assess needs • Provide resources, coordination and communication among participating groups and with other consortia (website, portal, meetings) • Facilitate and expedite research implementation and translational process • Performance evaluation: in cooperation with investigators, develops milestones and “best practices” • Involvement in planning and liaison with other agencies/institutions

  11. Emerging Consortia: Criteria for Evaluation (EGRP-CWG) Emerging consortium: a group of three or more groups of investigators from different institutions planning to launch a joint initiative by combining resources from case-control, familial or cohort studies. Criteria: • Scientific rationale and justification of need : what are the scientific questions that only the consortium can address • Preliminary rationale that large numbers are needed to address questions outlined in #1 • Outline of proposed internal leadership and organizational structure • Outline of guidelines for sharing of data and specimen resources and publication policies • Tabulation of similarities and differences in design, data variables, and specimen acquisition and storage (if applicable) across studies • Proposed plan to address informed consent issues  

  12. Consortia Challenges and Possible Solutions (CWG)

  13. …and More

  14. The Breast and ColonCancer Family Registry A Hypothesis-Driven Research Infrastructure Sponsored by the National Cancer Institute http://epi.grants.cancer.gov/CFR/

  15. BC-CFR Objectives • To establish a comprehensive research resource infrastructure to assist with the implementation of collaborative, interdisciplinary research protocols in the genetic epidemiology of breast, ovarian, colon and related cancers • To identify, characterize, and follow-up a cohort of individuals and their family members, spanning the spectrum of cancer risk • To identify diverse genetically susceptible populations that could benefit from enrollment in preventive and therapeutic interventions • To develop an adaptive and evolving informatics model to support ongoing and future research consortia

  16. (Phase I, Phase II, Proposed Phase III) BC-CFR Funding Support BC-CFRs Components Funding

  17. BC-CFR Sites Colon CFR: • Australia Consortium, University of Melbourne • John Hopper • Cancer Care Ontario • Steve Gallinger • Fred Hutchinson Cancer Research Center, Seattle • John Potter • Mayo Clinic • Noralane Lindor • Cancer Research Center of Hawaii • Loic Le Marchand • USC (LA) Consortium • Robert Haile • Affiliated Sites – Galicia, Spain; Newfoundland, Canada; Northern California Cancer Center Breast CFR: • Australia Consortium,University of Melbourne • John Hopper • Fox Chase Cancer Center, Philadelphia • Mary Daly • Metropolitan New York • Ruby T. Senie • Northern California Cancer Center • Esther M. John • Cancer Care Ontario • Irene Andrulis • University of Utah, Huntsman Cancer Institute • Saundra Buys

  18. BC-CFR Organizational Structure NCI Program Officer Core Working Groups Steering Committee Advisory Committee Research Working Groups Six Awarded Sites (and Affiliates) Informatics Center Adapted John et al. Breast Cancer Res 2004

  19. Design of the BC-CFR ParticipatingSites (U01s) Informatics Center (Contract) Biospecimen Repositories Family History Risk Factors Qs Clinical/Pathology Biospecimen Tracking Follow-up Molecular Characterization Informatics Units Pilot Studies C O L L A B O R A T I V E S T U D I E S FAMILIES Population Based Clinic-based Central Registry Data Base Molecular Genetics Laboratories

  20. BC-CFR Core Activities Core Activities • Follow-up of enrolled proband/families and new families • Molecular characterization (mutational/genotyping) • Biospecimen repositories • Virtual tissue repository • Informatics Support • Administrative, travel and coordination • Accrual of new probands/families • Minorities/ethnic projects • Ashkenazi* Additional Activities • Pilot/ancillary projects • Establishment of fresh frozen tissue repository

  21. Adapted from Study Designs to Identify and Characterize Disease Susceptibility Genes, AS Whittemore and LM Nelson, JNCI Monograph 26, 1999 BC-CFR Core Study Designs(Genetic Epidemiology)

  22. B-CFR Consented Participants Collected (1997-2004)

  23. C-CFR Consented Participants Collected (1997-2004)

  24. Strengths of BC-CFR • Dual-ascertainment • Families across spectrum of risk • Large sample size • Quality and comprehensive collection • Establishment of immortalized cell lines • Interdisplinary team of experts • Development of collaborative projects • Flexibility in study design • Prospective follow-up and data collection • Diverse sample • Race/ethnicity • International sites • Isolated populations (Ashkenazi Jewish and Newfoundland)

  25. Designs for Studying Association in the CFRsD. Thomas, Genetic Epidemiology • Population-based case-control studies • Family-based designs: • Case-parent triads • Discordant sibships • Kin-cohort designs • Case-control family designs • High-risk family designs

  26. BC-CFR Review Process Advisory Committee Review (scientific merit) Steering Committee Review (availability of data/biospecimen; conflict of interest) Access to BC-CFR infrastructure granted P.I seeks funding for research project Contact: Alysa Lesemann (Scientific Review Coordinator) lesemana@mail.nih.gov

  27. Applications for BC-CFR Collaborative Projects Total # 122 B-CFR Total # 98 C-CFR

  28. Cumulative Publications from BC-CFR Peer-Approved Research Projects Total # 117 B-CFR Total # 41 C-CFR

  29. We Still Have a Long Way to Go

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