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Subra Kugathasan, MD
Emory University
(E): [email protected]
(P): 404-727-4542
Marla Dubinsky, MD
Cedars-Sinai Medical Center
(E): [email protected]
(P): 310-423-7100
Robert (Bob) Baldassano, MD
Children’s Hospital of
Philadelphia
(E): [email protected]
(P): 267-426-5123
Bruce Aronow, PhD
Cincinnati Children’s Hospital
(E): [email protected]
(P): 513-636-0263
Lee (Ted) Denson, MD
Cincinnati Children’s Hospital
(E): [email protected]
(P): 513-636-7575
Jeffrey (Jeff) Hyams, MD
Connecticut Children’s Medical
(E): [email protected]
(P): 860-545-9532
James (Jim) Markowitz, MD
Feinstein Institute for Medical Research
(E): [email protected]
(P): 718-470-3430
Thomas (Tom) Walters, MD
Sick Kids, Canada
(E): [email protected]
(P): 416-813-5143
Michael Stephens, MD
Medical College of Wisconsin
(E): [email protected]
(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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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) [email protected] Tel: 404-727-4542
Cary Sauer, MD [email protected] Tel: 404-712-2160
Courtney Galloway [email protected] Tel: 404-727-5292 Fax: 404-727-4069
2 Cedars-Sinai Medical Center
Marla Dubinsky, MD [email protected] Tel: 310-423-7100
Shervin Rabizadeh, MD [email protected]
Sharmayne Farrior, RN, BSN [email protected] Tel: 310-423-1686 Fax 310-423-1402
3 Children’s Hospital of Philadelphia
Robert (Bob) Baldassano, MD [email protected] Tel: 267-426-5123
Andrew Grossman, MD [email protected] Dr. Judith Kelsen, [email protected].
Ashley Martin [email protected] Tel: 267-426-3194 Fax: 267-426-5146 Adriane Rozmarynowski
4 Cincinnati Children’s Hospital Medical Center
Lee Denson, MD (Ted)[email protected] Tel: 513-636-7575
Charles Samson, MD [email protected]
Kathleen (Katie) Lake, MSW, LISW, CCRC [email protected] Tel: 513-636-0572 Pager: 513-577-1038
5 Connecticut Children’s Medical Center
Jeffrey Hyams, MD (Jeff) [email protected] Tel: 860-545-9532
Francisco Sylvester, MD [email protected] Donna Zeiter, MD [email protected]
Miriam Lincoln [email protected] Tel: 860-545-9540 Fax: 860-545-9852
6 Medical College of Wisconsin
Michael Stephens, MD [email protected] Tel: 414-813-5143
Vincent Biank, MD [email protected] Joshua Noe, MD [email protected]
Nicholas Peterson [email protected] Tel: 414-266-4844 Fax: 414266-3676
7 Feinstein Institute for Medi-cal Research
James Markowitz, MD (Jim) [email protected] Tel: 718-470-3430
None Kathy Grancher, RN [email protected] Tel: 718-470-3363
8 University of California, San Francisco
Mel Heyman, MD [email protected] Tel: 415-476-5892
Neera Gupta, MD [email protected] 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 [email protected] Tel: 832-822-1051
George Ferry, MD [email protected] Antone Opekun, PA-C [email protected]
Sahna Reedy [email protected] Tel: 713-705-7227
12 University of North Carolina, Chapel Hill
Sandy Kim, MD [email protected] Tel: 919-966-0745
Michael Kappelman, MD [email protected] 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 [email protected] Tel: 416-813-8757
Thomas Walters, MD [email protected]
Karoline Fiedler [email protected] Tel: 416-813-6858
14 AHS Hospital Corporation Joel Rosh, MD [email protected] Tel: 973-971-5676
Tamara Feldman, MD [email protected] Tel: 973-971-5676
Annette Langseder, RN [email protected] Tel: 973-971-7747
15 IWK Health Centre Anthony Otley, MD [email protected] Tel: 902-470-8746
Mohsin Rashid, MD, MEd, FRCPC [email protected]
Brad MacIntyre, BSc. Hons. [email protected] Tel: 902-470-7009
16 Indiana University School of Medicine
Marian Pfefferkorn, MD [email protected] Tel: 317-274-3774
Steven Steiner, MD [email protected]
Trisha Davis, RN [email protected] Tel: 317-948-5858
17 Children’s Center for Digestive Health, LLC.
Stanley Cohen, MD [email protected]
Benjamin Gold, MD [email protected]
Tamara Wakhisi, MS [email protected] Tel: 404-503-2263 Shirley Duong
18 University of Utah Stephen Guthery, MD [email protected] Tel: 801-585-3616
John Pohl, MD [email protected]
Ann Rutherford, CCRP [email protected] Tel: 801-585-9495
19 Rhode Island Hospital Neal LeLeiko, MD [email protected] Tel: 401 444 8496
Jared Silverstein, MD [email protected] Tel: 401-444-8306
Barbara Bancroft, MS, RN [email protected] Tel: 401-444-2884
20 Johns Hopkins Children’s Center
Maria Oliva-Hemker, MD [email protected]
Carmen Cuffari, MD [email protected] Tel: 410-614-6144 Anthony Guerrerio, MD, PhD [email protected]
Vivian Abadom, RN, BSN, MT, PhD [email protected] Tel: 410-955-0779 Fax: 410-955-1464
21 University of Pittsburgh David Keljo, MD [email protected] Tel: 412-692-5180
Alka Goyal, MD [email protected] Tel: 412-692-5180
Sandra McRandal, MSN, CRNP [email protected] Tel: 412-692-8453
22 Vanderbilt University Dedrick Moulton, MD [email protected] Tel: 615-322-7449
Michael Rosen, MD [email protected]
Cynthia Womack-Ramirez, LPN [email protected] Tel: 615-322-4137
23 University of Chicago Barbara S. Kirschner, MD [email protected] Tel: 773‐702‐6418
Ranjana Gokhale, M.D. [email protected] Stacy Kahn, MD [email protected]
Thomas Mangatu [email protected] Tel: 773-702-4621 Matthew Tierney, CCRC [email protected] Tel: 773-702-6418
24 UT Southwestern Medical Center at Dallas
Ashish Patel, MD [email protected] Tel:214-456-5753
John Andersen, MD [email protected]
Sharon Judy [email protected] Tel: 214-456-2269
25 UCLA Medical Center David Ziring, MD [email protected]
None Jane Fung [email protected] 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
[email protected] 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
[email protected] Tel: 646-943-7484 Fax: 212-779-4098
Clinipace Clint Hall Senior Project Manager
3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560
[email protected] 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
[email protected] Tel: 404-727-4542 Fax: 404-727-4069
Jon Waters Research Specialist Shipping, Samples & Storage
2015 Uppergate Drive Suite 260 Atlanta, Georgia 30322
[email protected] Tel: 404-727-2352 Fax: 404-727-4069
Hospital for Sick Children Thomas (Tom) Walters, MD Chart design, data collection.
[email protected] Tel: 416-813-5143
Cincinnati Children’s Hospital Medical Center
Bruce Aronow PhD Bioinformatics and Biostatistics
[email protected] Tel: 513-636-0263 Fax: 513-636-2056
Cincinnati Children’s Hospital Medical Center
Mi-Ok Kim, PhD Biostatistics
[email protected] 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 [email protected]
Jill Dorsey, MD [email protected]
Margaret (Peg) Thorne, RN [email protected] 904-697-2043
27 The Research Foundation of SUNY on behalf of the University of Buffalo
Susan S. Baker, MD [email protected] Tel: 716-878-7793
None Christine M. Roach, RN, BSN [email protected] Tel: 716-878-7199 Lynne Adamczyk
28 The Children’s Hospital and University of Colorado, Denver
Edward J. Hoffenberg, MD [email protected] Tel: 720-777-6669
None Michelle Hite, MA, CRC [email protected] Tel: 720-777-4690
29 Children’s Hospital of Eastern Ontario
David Mack, MD [email protected] Tel: 613-737-7600 ext 2516
Dr. Margaret Boland [email protected]
Ruth Singleton, RN [email protected] Tel: 613-737-7600 ext. 4113 Jane Earle / / Amanda Mack