The Mayo Clinic Biorepository Program FINAL

8/9/2019 The Mayo Clinic Biorepository Program FINAL

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©2012 MFMER | slide-

CENTER FOR

INDIVIDUALIZED

MEDICINE

Biorepositories ProgramStephen Thibodeau, PhD, FACMG


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Center for INDIVIDUALIZED MEDICINE

Translational Programs

InfrastructurePrograms

Biorepository

Medical

Genome Facility

InformationTechnology

BiomedicalInformatics

Bioethics

Administration

Pharmaco-genomics

Biomarker discovery Clinomics Epigenomics Microbiome

Center for Individualized Medicine


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• What is a biorepository?• Collection of biologic samples, typically blood, tissue,

urine, stool, but can be any patient material.

• Information about the sample

• Associated clinical information about the patient at thetime of collection

• Why are biorepositories important?• Central to discovery and translational research for all

human disease• Understanding the basis of disease

• Improved methods for detection, prognosis, predictionand treatment

Mayo Clinic Biorepositories


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• Not new!

• Specimen collection ongoing for more than 100years.• Paraffin embedded tissue from specimens removed at

surgery have been archived from the beginning

• Large number of investigator-driven disease-oriented collections for blood and tissue• Cancer

• Neurologic disorders

• Cardiovascular disease

• Etc.

Mayo Clinic Biorepositories


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• Help as many Mayo investigators as possibleto support their research programs

• Increase competitiveness of Mayo

Investigators for national grants (NIH)

• Accelerate research, discovery and translationinto clinical practice

• Prepare Mayo for the future of Medicine

Biorepository Program - Goals


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Infrastructure

Facilities at three Mayo Clinic sitesMinnesota, Florida and Arizona

Biospecimen Accessioning and Processing (BAP)Provides processing of all types of biologic samples,including kit building, accessioning, processing, storage,distribution and management of samples.

Pathology Research (PRC)Provides histology-related services, including

immunohistochemistry, tissue microarray construction,digital imaging, and laser capture microdissection.


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BAP – Services & Volumes/Year

Service Number TypeAccessioning 56,814 Collection eventsAliquoting, Automated 216,000 Tubes CreatedAliquoting, Manual 144,000 Tubes CreatedPull from Storage 24,893 TubesReturn to Storage 23,648 TubesPlating 514 PlatesDNA/RNA Extraction 26,000 SamplesNA Quantification 32,000 SamplesCirculating tumor cells 1,500 SamplesKits 4,000 Kits madeTotal Storage 2,500,000 Tubes


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PRC – Services & Volumes/Year

Service Number

FFPE Sectioning 85,000

Frozen Sectioning 20,000

IHC Optimization 80

IHC Staining 15,000

Laser Capture Microdissection 200

Imaging - TMA Sections 500

Imaging - Whole Tissue Sections 4,500Re-Embedding (non clinical blocks) 500

TMA Construction 50


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Storage and Sample Management

• Conventional and liquid nitrogen Freezers

• Robotically controlled freezers

• 1 Brooks robotic freezers

• 0.6 Million tube capacity

• Hamilton Bios

• 3.5 Million tube capacity

• Room for 10M expansion

• Develop robust disaster planRochester


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• Centralize facility for sample processing,storage and management

• Standardize operating procedures• Improve quality

• Improve efficiencies

• One stop shop!

New Facility - Goals


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Mayo Clinic Biobank


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Mayo Clinic Biobank

• A CIM initiative launched in 2007• To enroll 50,000 Mayo patients regardless of their health

history (no specific disease)

• To provide an institutional resource for a wide array of health-related research and clinical studies

• A new way to conduct research at Mayo• Risk factor data, medical records and specimens to be used

in multiple studies

• Each study has its own IRB approval

• No “re-consenting” for each study

• Results incorporated back into the Biobank for reuse


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Consent Form

• Allows for use of specimens and data inunlimited studies (“registry” consent)

• Allows for past and future access to medical

record

• Allows for future contact (up to 2x/year)

• Certificate of Confidentiality

• Plans for longitudinal collections


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Health History Questionnaire

• Topics

• Demographics

• General health status

• Quality of life

• Personal & familymedical history

• Female & male health hx

• Health behaviors

• Environment


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Blood Sample

• 3 - 10 ml EDTA tubes

• For DNA, buffy coat, plasma

• Some of these to be spun twice to obtain platelet-free plasma

• 1 - 10 ml no additive (for serum)

• 1 - 4.5 ml Sodium Citrate (for plasma)

• For a subset of subjects (~ 2000)• 1 - 6 ml Sodium Heparin tube (for slow-freezing)


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50,000 Consented

Female

58%Male

42%

Olmsted

40%SE

MN

17%

Rest

of

MN

16%

IA

6%

WI

4%

Dakotas 1%Other US 15%


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Community Advisory Board

• CAB was developed to guide Biobank activities

• Activities of CAB:• Advise on management and operation of biobank(s)

• Review policies governing access to research samples

• Evaluate patient materials

• Suggest plans for community education

• Consider complex policy decisions such as return of results to participants


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Education / Communication

• Web sites• Just search “ Mayo Clinic Biobank ”

• External – for participantshttp://mayoresearch.mayo.edu/biobank/

• Internal – for clinicians and investigators

http://mayoweb.mayo.edu/biobanks/controls-collection.html

• Newsletters Springand Fall

• Videos


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Projects Using the Biobank

• Over 150 projects approved (6-2013)• ~72,000 total samples/data requested

• Example Controls for Case-Control Studies (DNA):

• CLL (N=500), Susan Slager

• Breast Cancer (N=1000), Fergus Couch• Myeloma (N=1000), Celine Vachon

• Glioma (N=500), Robert Jenkins

• Colon Cancer (N=500), Lisa Boardman

• Peripheral arterial disease (N=2,000), Iftikar Kullo

• Resistant hypertension (N=230), Iftikar Kullo

• Example Controls for sequencing studies

• PKD (N=250), Peter Harris (return of results)

• Full exomes (N=90), Steve Thibodeau


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• Why Mayo? Why now?

• One of the largest collections in the country withongoing access to detailed medical records

• The power and cost of sequencing continue toimprove

• Will be necessary to fill an enormous gap in ourunderstanding of the human genome and of human

health and disease

Whole Genome Sequence


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Whole Genome Sequence

• Benefit to Mayo• Generate an enormous amount of information on health and

disease that can be used for discovery

• Data can be used by an ever growing number of investigators,over and over again

• Crucial for CIM and Mayo to be competitive in the coming years.

• Continue to place Mayo Clinic and CIM in a leadership positionat a national level (NIH and White House initiatives)

• Develop novel diagnostics, novel clinical assays, and improved

ability to predict the occurrence of disease and disease outcomes


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Principles for Use of Biobank

• Projects approved by Mayo Clinic InstitutionalReview Board

• Peer-review of projects to assure high-qualityscience

• Samples are only given for a specific purpose andamount required for study

• Researchers do not know the identity of the

participant – anonymous

• Study data are returned to the Biobank


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Strengths

• Embedded in Mayo clinical practice• Takes advantage of general medicine patient populations –

cost effective

• Most participants have a long length of time in the medical

record

• Leverages the EMR and Natural Language Processingresearch at Mayo

• Robust ethics and community input

• Can interface with the Rochester Epidemiology Project

• Re-use of data


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Biobank Participant Data The 10 most common prevalent diseases by self-report included: - hyperlipidemia (41%) - hypertension (38%) - osteoarthritis (30%) - gastro-esophageal reflux disease (26%) - cataracts (24%)

- depression (22%) - abnormal distance vision (21%) - migraine (18%) - anxiety (17%) - sleep apnea (15%) The 5 most common prevalent cancers include: - non-melanoma skin cancer (14%) - prostate cancer (12%)

- breast cancer (4%) - melanoma (3%) - colorectal cancer (1.4%).

Documents

The Mayo Clinic Biorepository Program FINAL