Subra Kugathasan, MD

Emory University

(E): skugath@emory.edu

(P): 404-727-4542

Marla Dubinsky, MD

Cedars-Sinai Medical Center

(E): marla.dubinsky@cshs.org

(P): 310-423-7100

Robert (Bob) Baldassano, MD

Children’s Hospital of

Philadelphia

(E): baldassano@email.chop.edu

(P): 267-426-5123

Bruce Aronow, PhD

Cincinnati Children’s Hospital

(E): bruce.aronow@cchmc.org

(P): 513-636-0263

Lee (Ted) Denson, MD

Cincinnati Children’s Hospital

(E): lee.denson@cchmc.org

(P): 513-636-7575

Jeffrey (Jeff) Hyams, MD

Connecticut Children’s Medical

(E): jhyams@ccmckids.org

(P): 860-545-9532

James (Jim) Markowitz, MD

Feinstein Institute for Medical Research

(E): jmarkowi@nshs.edu

(P): 718-470-3430

Thomas (Tom) Walters, MD

Sick Kids, Canada

(E): thomas.walters@sickkids.ca

(P): 416-813-5143

Michael Stephens, MD

Medical College of Wisconsin

(E): mstephen@mcw.edu

(P): 416-813-5143

Page 1: It’s Getting Colder!!! Page 2: Site Enrollment Numbers

Page 3: Center Highlight - Children’s Hospital of Philadelphia Page 4: Conference call Highlights

Page 5: Enrollment Projection Charts Page 6: Clinipace Data Information Page 7: Advances Meeting Agenda

Page 8-10: Site Contact Information

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2015 Uppergate Drive, Suite 241B, Atlanta, GA 30322 Tel: 404-727-4542 S T E E R I N G

IN THIS ISSUE:::

NEXT CONFERENCE CALL Friday, November 18 2011- 12:00 - 1:00 p.m.

Toll-free dial in number: 877-452-6857 Conference code: 607869685

Risk Stratification Project Newsletter S P O N S O R : C R O H N ’ S A N D C O L I T I S

F O U N D A T I O N O F A M E R I C A

Editorial Support: Laketia Woodley

P A G E 2 S I T E E N R O L L M E N T N U M B E R S

Caption describing picture or

graphic.

SITE # SITE NAME STUDY COORDINATOR TOTAL PATIENTS

ENROLLED

1 Emory University Courtney Galloway 101

2 Cedars-Sinai Medical Center Sharmayne Farrior, RN, BSN 48

3 Children’s Hospital of Philadelphia Ashley Martin 155

4 Cincinnati Children’s Hospital Kathleen Lake, MSW, LISW, CCRC 120

5 Connecticut Children’s Medical Center Miriam Lincoln 147

6 Medical College of Wisconsin Nicholas Peterson 99

7 Feinstein Institute for Medical Research Kathy Grancher, RN 65

8 University of California, San Francisco Alisa Richardson 54

9 Nationwide Children’s Center—Ohio Stacy Ballam 66

10 Children’s Hospital Boston Ben Atkinson 45

11 Baylor College of Medicine Sahna Reedy 54

12 University of North Carolina at Chapel Hill Katherine McLennan 35

13 Sick Kids, Canada Karoline Fiedler 161

14 AHS Hospital Corporation Annette Langseder, RN 44

15 IWK Health Centre Brad McIntyre, BSc. Hons. 27

16 Indiana University School Of Medicine Trisha Davis, RN 24

17 Children’s Center for Digestive Health Tamara Wakhisi, MS 26

18 University of Utah Ann Rutherford, CCRP 36

19 Rhode Island Hospital Barbara Bancroft, MS, RN 35

20 Johns Hopkins University Vivian Abadom, RN, BSN, MT, PhD 24

21 University of Pittsburgh Sandy McRandal, MSN, CRNP 27

22 Vanderbilt University Cynthia Womack-Ramirez, LPN 37

23 University of Chicago Thomas Mangatu 17

24 UT Southwestern Medical Center at Dallas Judy Sharon 19

25 UCLA Medical Center Jane Fung 9

26 Nemours Children’s Clinic Margaret Thorne, RN 11

27 The Research Foundation / Univ. of Buffalo Christine Roach, RN, BSN 41

28 The Children’s Hospital University of Colorado, Denver

Michelle Hite, MA, CRC 0

29 Children’s Hospital of Eastern Ontario Ruth Singleton, RN 34

TOTAL NUMBER OF PATIENTS ENROLLED 1561

1 YEAR F/U

33

14

23

64

38

26

10

6

25

19

5

9

45

8

10

6

1

7

3

0

0

0

0

0

2

2

1

0

0

363

2ND YEAR

F/U

15

7

13

33

9

11

3

0

0

0

0

0

1

12

10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

92

3RD YEAR

F/U

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

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P A G E 3

CENTER HIGHLIGHT– Children’s Hospital of Philadelphia Principal Investigator: Robert (Bob) Baldassano, MD Coordinator: Ashley Martin Co-Investigator: Andrew Grossman, MD Dr. Judith Kelsen,

Total Patients Enrolled: 155 Average Enrollment Per Month: 6

The Children’s Hospital of Philadelphia (CHOP) is the nation’s first pediatric hospital and is affiliated with the University of Pennsylvania. The main cam-pus is located in Philadelphia, Pennsylvania with outpatient and ambulatory centers in the extensive Philadelphia suburbs. Our division of Gastroenterol-ogy Hepatology & Nutrition consists of 34 Attendings and 16 fellows. GI patients are seen on the main campus as well as in eight satellite locations. The Center for Pediatric Inflammatory Bowel Disease at The Children's Hos-pital of Philadelphia is one of the largest centers of its kind in the United States. We care for approximately 1,600 children a year with IBD, who seek care here from all over the world. The center is committed to providing com-

prehensive cutting edge treatment for children with Inflammatory Bowel Disease through educa-tion, research, and supportive services. Currently, we have eight research coordinators diligently working on numerous inflammatory bowel disease studies, dedicated to improving the quality of life for these children and their families. Dr. Robert Baldassano is our site PI and Director of the Pediatric Center for Inflammatory Bowel Disease. Dr. Baldassano plays an integral role in IBD research and has been recognized internationally for his commitment to un-derstanding the disease and improving patient care. He is an inspiration to those he works with and continues to encourage others around him to remain focused on finding the cause to eventually prevent the disease. Ashley Mar-tin is the lead study coordinator who has committed herself to the Risk Strati-fication study. The key to our success is reviewing the endoscopy schedule, developing and maintaining strong working relationships with Attendings and fellows, along with monitoring the patients admitted to CHOP. Once potential patients have been identified, the child’s physician is

contacted to discuss if it is appropriate to discuss participation in research with the family. Consent for the study is obtained on the day of the procedure. With the help of Attendings, fellows, and nurses we have been quite successful! As enrollment is coming to an end our focus will be overcoming the challenges of capturing follow ups not seen on the main campus. We look forward to the exciting discoveries RISK will bring and the door the repository opens for future ancillary studies.

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Dr. Robert Baldassano Principal Investigator

Ashley Martin Coordinator

CONFERENCE CALL HIGHLIGHT 10/28/2011

P A G E 4

QUICK NOTES: Next time we speak will be at the Ad-vances meeting. We hope that everyone will be there to see what we have to say about the progress. Currently have 1561 sub-

jects enrolled.

DATACARD: Datacard from the database shows the chrono-status as of October 24th. We have 14-18 subjects enrolled data-base wise. 85% of the subjects have IBD. * 12% IBD-U * 8% Ulcerative colitis 15% are none IBD. Based on these numbers, our pro-jection shows we will have about 1700-1800 patients enrolled by the end of the year and we will cease enrollment. Well have over 1200 Crohn’s patients by then.

First 36-month review shows that we have only lost 5% of the patients to follow-up which is good compared to the 10% we projected. Sites have an-other 2 months to enroll and boost their numbers. Set goals and aims to reach higher en-rollment numbers before the project ends.

DATABASE CLEAN-UP: All sites should be receiving quires from Tom Walters and Cathy Brashear to clean up the data and quality control of the database. So please try to com-

plete as soon as possible.

Serology Immunochip: Being developed by Illumina and involves 200,000 SNIPS. Not a GWAS but close and is overpopulated with all the loci associated with IBD. Wonderful screening tool that we will be using and we hope to percent that data to you in terms of genetic Crohn’s and gene expression at the meeting.

Ted Denson is doing the gene ex-pression array on patients who have stricturing disease . Today 8% of patients enrolled have developed complicated or stricturing disease . We think the projections are really close to what we originally pro-jected.

Very excited in regards to develop-ment and enrollment.

PLEASE SEE FULL AGENDA ON PAGE 7

Annual Risk Stratification Investigator Meeting Agenda:

Starting at 11:30 with lunch and the meeting will begin by 12:30pm Serology Data will be completed

and presented.

At least 1000 Crohn’s patients enrolled.

One year follow-up data on pa-tients will be presented.

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One more conference call on Novem-ber 18th before advances meeting.

Listen to recorded Conference call

Here

OTHER NEWS::::

DONT FORGET ABOUT THE 2011 ADVANCES IN IBD CON-FERENCE IN HOLLYWOOD

FLORIDA, DECEMBER 1ST - 4TH. Please

click the link HERE for conference and registration information.

Questions about Enrollment?? Can you enroll normal patients? Yes but no reimbursement. Will negotiate next year. AN EMAIL was sent out asking to in-quire with any patient enrolled that has a serious complication that required a blood transfusion or hospitalization as a result of biopsy. No answers have been received but if there are any, please reply to that email so the information can be documented.

INVOICES: A lot of invoices have been received. Please note than when you send invoices they will be reviewed and

compared to the database before any site is paid. CRF and samples are paid based on them being input into Clinipace. Please ensure that what you are invoicing for is updated in the data-base. DATABASE: There are about 100 patients in the database that need to be cleaned up and therefore are not accounted for. IN CLOSING: No questions from sponsors or site representatives.

Enrollment Projection Charts P A G E 5

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P A G E 6 M

ON

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Database Information

Current Status of FU (24th Oct 2011)

0

200

400

600

800

1000

1200

1400

1600

Missing Dx

Lost to FU

Missed Visit

Not IBD

IBD‐U

UC

CD

Late Review

* Please note that there is a time lack from when an enrollment occurs and when data is loaded into the database/the phenotypic data is generated.

PRO-KIIDS Data Centre

P A G E 7

ANNUAL RISK STRATIFICATION INVESTIGATOR MEETING AGENDA

Meet&GreetLuncheon11:30am–12:30pm

12:30 Welcome‐SubraKugathasan&CathyBrashear

12:35 Progresstodate‐ClosureofEnrollmentandsiteperformance

PROGRESSREPORTAdministrativeCore

12:45 DataCoordination,IRB‐CathyBrashear

12:50

Laboratory‐JonWalters/DavidOkou

12:55 FinancialandInvoicing‐LaketiaWoodley

GENETIC,SEROLOGY&MICROARRAYCOREREPORTS

1:00Genetic‐SubraKugathasanSerology‐MarlaDubinskyMicroarray‐TedDenson

1:15NewCore‐Microbiome‐NewInitiatives(funding,RFAandmore)FranciscoSylvesterandSandyKim

PRELIMINARYDATAPRESENTATION

1:30 PhenotypingandDataRepository‐TomWalters

1:45 ImmunochipandBeyond–Initialanalysis SteveGutheryandSubraKugathasan

2:00 MicroarrayandGeneExpression‐TedDenson

2:15 DataAnalysisI–MiokKim

2:30 DataAnalysisII‐BruceAronow

2:45 DataAnalysiswrapupandDDWabstracts‐ SubraKugathasan

BREAK2:45‐3:00pm

PROTECT(pediatricUCtrialupdate,sponsor:NIH)

3:00 Clinicaltrialprotocolupdate,sitedesignations,timetableforevents,IRBs,sub‐contracts,datasystems,investigator’smeeting,studystart JeffreyHyams,TedDenson&TomWalters

THEFUTURE:Projects,Investigatormeeting,etc.

3:45 AncillaryStudiesupdate–TedDenson

4:10 AncillaryStudies–mechanism&cost

4:15 NextSteps/NIHApplication

OpenForum–Discussion 4:30‐5:00

P A G E 8

SITE CONTACTS:

SITE # SITE PI CO-PI / BACK UP PERSONNEL

STUDY COORDINATOR/ BACK-UP PERSONNEL

1 Emory University

Subra Kugathasan, MD (PI) skugath@emory.edu Tel: 404-727-4542

Cary Sauer, MD csauer@emory.edu Tel: 404-712-2160

Courtney Galloway cbchile@emory.edu Tel: 404-727-5292 Fax: 404-727-4069

2 Cedars-Sinai Medical Center

Marla Dubinsky, MD marla.dubinsky@cshs.org Tel: 310-423-7100

Shervin Rabizadeh, MD shervin.rabizadeh@cshs.org

Sharmayne Farrior, RN, BSN sharmayne.farrior@cshs.org Tel: 310-423-1686 Fax 310-423-1402

3 Children’s Hospital of Philadelphia

Robert (Bob) Baldassano, MD baldassano@email.chop.edu Tel: 267-426-5123

Andrew Grossman, MD grossmanan@email.chop.edu Dr. Judith Kelsen, kelsen@email.chop.edu.

Ashley Martin martina1@email.chop.edu Tel: 267-426-3194 Fax: 267-426-5146 Adriane Rozmarynowski

4 Cincinnati Children’s Hospital Medical Center

Lee Denson, MD (Ted)lee.denson@cchmc.org Tel: 513-636-7575

Charles Samson, MD charles.samson@cchmc.org

Kathleen (Katie) Lake, MSW, LISW, CCRC kathleen.lake@cchmc.org  Tel: 513-636-0572 Pager: 513-577-1038

5 Connecticut Children’s Medical Center

Jeffrey Hyams, MD (Jeff) jhyams@ccmckids.org Tel: 860-545-9532

Francisco Sylvester, MD fsylves@ccmckids.org Donna Zeiter, MD dzeiter@ccmckids.org

Miriam Lincoln mlincoln@ccmckids.org Tel: 860-545-9540 Fax: 860-545-9852 

6 Medical College of Wisconsin

Michael Stephens, MD mstephen@mcw.edu Tel: 414-813-5143

Vincent Biank, MD vbiank@mcw.edu Joshua Noe, MD jnoe@mcw.edu

Nicholas Peterson nperterso@mcw.edu Tel: 414-266-4844 Fax: 414266-3676

7 Feinstein Institute for Medi-cal Research

James Markowitz, MD (Jim) jmarkowi@nshs.edu Tel: 718-470-3430

None Kathy Grancher, RN kgranche@nshs.edu Tel: 718-470-3363

8 University of California, San Francisco

Mel Heyman, MD mheyman@peds.ucsf.edu Tel: 415-476-5892

Neera Gupta, MD ng719@yahoo.com Tel: 415-476-5892

Alisa Richardson richardsonA.peds.ucsf.edu Tel: 415-476-6997 Fax: 415-476-1343

9 Nationwide Children’s Center - Ohio

Wallace Crandall, MD wallace.crandall @nationwidechildrens.org Tel: 614-722-3450

Ryan Carvalho, MD ryan.carvalho@ nationwidechildrens.org

Stacy Ballam stacy.ballam@ nationwidechildrens.org Tel: 614-722-3004 Fax:614-722-3454 Sarah Bistrick

10

Children's Hospital Boston

Jonah Essers, MD Jonah.essers@childrens. harvard.edu

Richard Grand, MD Richard.grand@ childrens.harvard.edu Tel: 617-355-4405

Ben Atkinson Benjamin.atkinson@childrens. har-vard.edu Tel: 857-218-4979 Sarah Weber

11 Baylor College of Medicine

Richard Kellermayer, MD kellerma@bcm.tmc.edu Tel: 832-822-1051

George Ferry, MD gdferry@texaschildrens.org Antone Opekun, PA-C aopekun@bcm.tmc.edu

Sahna Reedy sahnar@bcm.edu Tel: 713-705-7227

12 University of North Carolina, Chapel Hill

Sandy Kim, MD skim@med.unc.edu Tel: 919-966-0745

Michael Kappelman, MD michael_kappelman@med.unc.edu Tel: 919-966-1343

Katherine MacLennan, BSN, RN Tel: 919-843-9547 Fax: 919-966-8641

SITE CONTACTS CONT’D

SITE # SITE PI CO-PI / BACK UP PERSONNEL

STUDY COORDINATOR/ BACK UP PERSONNEL

13 Hospital for Sick Children (Toronto Sick kids )

Anne Griffith, M.D anne.griffiths@sickkids.ca Tel: 416-813-8757

Thomas Walters, MD thomas.walters@sickkids.ca

Karoline Fiedler karoline.fiedler@sickkids.ca Tel: 416-813-6858

14 AHS Hospital Corporation Joel Rosh, MD joel.rosh@atlantichealth.org Tel: 973-971-5676

Tamara Feldman, MD tamara.feldman@atlantichealth.org Tel: 973-971-5676

Annette Langseder, RN annette.langseder@atlantichealth.org Tel: 973-971-7747

15 IWK Health Centre Anthony Otley, MD arotley@dal.ca Tel: 902-470-8746

Mohsin Rashid, MD, MEd, FRCPC mohsin.rashid@iwk.nshealth.ca

Brad MacIntyre, BSc. Hons. brad.macintyre@iwk.nshealth.ca Tel: 902-470-7009

16 Indiana University School of Medicine

Marian Pfefferkorn, MD mdelrosa@iupui.edu Tel: 317-274-3774

Steven Steiner, MD ssteiner@iupui.edu

Trisha Davis, RN tawilson@iupui.edu Tel: 317-948-5858

17 Children’s Center for Digestive Health, LLC.

Stanley Cohen, MD stancohen@aol.com

Benjamin Gold, MD bgold@ccdhc.org

Tamara Wakhisi, MS tgobin@ccdhc.org Tel: 404-503-2263 Shirley Duong

18 University of Utah Stephen Guthery, MD stephen.guthery@hsc.utah.edu Tel: 801-585-3616

John Pohl, MD john.pohl@imail.org

Ann Rutherford, CCRP ann.rutherford@hsc.utah.edu Tel: 801-585-9495

19 Rhode Island Hospital Neal LeLeiko, MD neal_leleiko@brown.edu Tel: 401 444 8496

Jared Silverstein, MD jsilverstein@lifespan.org Tel: 401-444-8306

Barbara Bancroft, MS, RN bbancroft@lifespan.org Tel: 401-444-2884

20 Johns Hopkins Children’s Center

Maria Oliva-Hemker, MD moliva@jhmi.edu

Carmen Cuffari, MD ccufari@jhmi.edu Tel: 410-614-6144 Anthony Guerrerio, MD, PhD aguerre1@jhmi.edu

Vivian Abadom, RN, BSN, MT, PhD vabadom1@jhmi.edu Tel: 410-955-0779 Fax: 410-955-1464

21 University of Pittsburgh David Keljo, MD david.keljo@chp.edu Tel: 412-692-5180

Alka Goyal, MD alka.goyal@chp.edu Tel: 412-692-5180

Sandra McRandal, MSN, CRNP sandra.mcrandal@chp.edu Tel: 412-692-8453

22 Vanderbilt University Dedrick Moulton, MD dedrick.moulton@vanderbilt.edu Tel: 615-322-7449

Michael Rosen, MD michael.rosen@vanderbilt.edu

Cynthia Womack-Ramirez, LPN cynthia.h.womack-ramirez@vanderbilt.edu Tel: 615-322-4137

23 University of Chicago Barbara S. Kirschner, MD bskirsch@peds.bsd.chicago.edu Tel: 773‐702‐6418 

Ranjana Gokhale, M.D. rgokhale@peds.bsd.uchicago.edu Stacy Kahn, MD skahn@peds.bsd.uchicago.edu

Thomas Mangatu tmangatu@bsd.uchicago.edu Tel: 773-702-4621 Matthew Tierney, CCRC mtierney@bsd.uchicago.edu Tel: 773-702-6418

24 UT Southwestern Medical Center at Dallas

Ashish Patel, MD ashish.patel@childrens.com Tel:214-456-5753

John Andersen, MD john.andersen@childrens.com

Sharon Judy Sharon.judy@childrens.com Tel: 214-456-2269

25 UCLA Medical Center David Ziring, MD dziring@mednet.ucla.edu

None Jane Fung jfung95014@gmail.com Tel: 310-206-0688 Fax: 310-205-0203

P A G E 9

SITE CONTACTS:

OTHER KEY CONTACTS Institute / Organization Project Managers Contact Information

Emory University Cathy Holt-Brashear Research Manager

2015 Uppergate Drive Suite 260 Atlanta, GA 30322

Cathy.holt.brashear@emory.edu Tel: 404-727-1190 Fax: 404-727-4069

Crohn’s & Colitis Foundation of America

Saleena J. Marria MS, MBA Research Project Manager

386 Park Avenue South 17th Fl. New York, NY 10016

smarria@ccfa.org Tel: 646-943-7484 Fax: 212-779-4098

Clinipace Clint Hall Senior Project Manager

3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560

chall@clinipace.com Tel: 919-224-8800 x1121

Emory University Laketia Woodley Sr. Research Project Coord. Dr. Subra Kugathasan Subcontracts, Payments & Invoices

2015 Uppergate Drive Suite 240B Atlanta, Georgia 30322

twoodle@emory.edu Tel: 404-727-4542 Fax: 404-727-4069

Jon Waters Research Specialist Shipping, Samples & Storage

2015 Uppergate Drive Suite 260 Atlanta, Georgia 30322

jwater3@emory.edu Tel: 404-727-2352 Fax: 404-727-4069

Hospital for Sick Children Thomas (Tom) Walters, MD Chart design, data collection.

thomas.walters@sickkids.ca Tel: 416-813-5143

Cincinnati Children’s Hospital Medical Center

Bruce Aronow PhD Bioinformatics and Biostatistics

bruce.aronow@cchmc.org Tel: 513-636-0263 Fax: 513-636-2056

Cincinnati Children’s Hospital Medical Center

Mi-Ok Kim, PhD Biostatistics

miok.kim@cchmc.org Tel: 513-636-1895 Fax: 513-636-7509

Data and Statistics

Prepared by Subra Kugathasan, MD.- Saleena J. Marria, MS, MBA - Laketia Woodley

26 Nemours Children’s Clinic Jonathan Evans, MD jevans@nemours.org

Jill Dorsey, MD jmdorsey@nemours.org

Margaret (Peg) Thorne, RN mthorne@nemours.org 904-697-2043

27 The Research Foundation of SUNY on behalf of the University of Buffalo

Susan S. Baker, MD sbaker@upa.chob.edu Tel: 716-878-7793

None Christine M. Roach, RN, BSN croach@upa.chob.edu Tel: 716-878-7199 Lynne Adamczyk

28 The Children’s Hospital and University of Colorado, Denver

Edward J. Hoffenberg, MD hoffenberg.edward@tchden.org Tel: 720-777-6669

None Michelle Hite, MA, CRC Hite.michelle@tchden.org Tel: 720-777-4690

29 Children’s Hospital of Eastern Ontario

David Mack, MD dmack@cheo.on.ca Tel: 613-737-7600 ext 2516

Dr. Margaret Boland boland@cheo.on.ca

Ruth Singleton, RN rsingleton@cheo.on.ca Tel: 613-737-7600 ext. 4113 Jane Earle / / Amanda Mack