Transcript Division of Surgical Research - George Washington University

Division of Surgical Research – Research,
Educational and Institutional Projects
Christine L. Carter, Ph.D., M.P.H.
Director of Surgical Research
Research Professor of Surgery
Tel: 202 741 3202
Cell: 202 468 5073
Research Activities/Initiatives
Since February, 2004
1. 9 Research Contracts Awarded/Pending:
5 Contracts Funded
4 Pending IRB/Contract Approval
2. 2 Educational Initiatives
Course “Conducting Research at GWU”
Ethicon Endosurgery Lab
3. 2 Institutional Initiatives
Center of Excellence in Bariatric Surgery
Obesity Center of Excellence – SMHS + SPHHS +
CNMC
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Research Activities/Initiatives
Funded Currently (5)
 2 Device Studies (Pacer)
 2 Tissue Studies
 1 Questionnaire Validation Study
Funded by Summer, 2005 (4 more)
 1 ACOSOG Clin Trial (Surg+Rad vs Surg)
 1 NovoNordisk Clin Trial (Factor VII)
 2 Drug Studies (Hemh.; Int-abd Inf)
Division of Surgical Research – Research Projects
Topic:
Gastric Pacing - Gastroparesis
Sponsor: Medtronic, Inc
Start/End Date: 4-04 – 4-06
Total $ 84K (10 patients)
Investigators: Nsien (PI), Brody, Carter, Drenon
TITLE: GASTRIC STIMULATION FOR VOMITING, NAUSEA AND
RELATED SYMPTOMS ASSOCIATED WITH GASTROPARESIS
USING ENTERRA ™ GASTRIC STIMULATION SYSTEM.
This is a device study for the treatment of chronic nausea and
vomiting associated with gastroparesis when conventional drug
therapies are not affective. Assessment of safety and
effectiveness of implanted neurostimulator device used to
control symptoms of gastroparesis.
Division of Surgical Research – Research Projects
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Topic: Gastric Pacing - Obesity
Sponsor: Transneuronix, Inc
Start/End Date: 5-04-5-06
Total $ up to 400K
Investigators: Brody(PI), Carter, Drenon
TITLE: SHAPE Screened Health Assessment &
Pacer Evaluation
This is a device study. Therapy indicated for the
treatment of obesity. Assessment of the safety and
effectiveness of Transcend® Implantable Gastric
Stimulation (IGS®) System to help obese patients
loose weight and keep the lost weight off.
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Gastroparesis is a stomach disorder in which food moves
through the stomach more slowly than normal. In some
patients, this condition results in severe, chronic nausea and
vomiting that cannot be adequately controlled by available
drugs. These patients have difficulty eating and may require
some form of tube feeding to ensure adequate nutrition.
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Enterra Therapy uses mild electrical pulses to stimulate the
stomach. This electrical stimulation helps control the
symptoms associated with gastroparesis including nausea and
vomiting.
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Enterra™ Therapy is indicated for the treatment of chronic
nausea and vomiting associated with gastroparesis when
conventional drug therapies are not effective.
Diabetes Mellitus/Gastroparesis
 Case Overview
 A 34-year-old diabetic man was referred
 with a 7-year history of severe
gastroparesis.
 He had been unable to tolerate
 or had been unresponsive to conventional
 medical therapy for this condition.
 He was recently seen in his local hospital
 emergency room due to his inability to
 maintain minimal nutritional intake
 where a nasogastric tube was placed to
 decompress the abdomen. He had been
 hospitalized 10 times in the last year and
 vomiting up to 6 times a day. He had lost
 approximately 100 pounds over the last
 four years. The patient had a T-half
 emptying time of 280 minutes with no
 isotope leaving the stomach for two
 hours.
 Treatment
 The patient underwent abdominal
 ultrasound, gastric and small intestinal
 motility studies and a gastric emptying
 study to confirm gastroparesis. It was
 decided that he was an excellent
 candidate for insertion of the gastric
 pacemaker device.
Division of Surgical Research – Research Projects
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Topic: Tissue Study in Young Colorectal Cancer Pts
Sponsor: NIH/ACOSOG
Start/End Date: 9-04 – 9-12
Total $ 2K per pt, n=10
Investigators: Orkin (PI), Katz (Co-PI), Schwartz
(Pathologist), Drenon
TITLE: ACOSOG Z0190.A PROSPECTIVE STUDY OF THE
PROGNOSTIC SIGNIFICANCE OF MICROSATELLITE
INSTABILITY(MSI) IN PATIENTS WITH EARLY AGE-OFONSET COLORECTAL CANCER.
Collection of diseased tissue from patients with a diagnosis
of colorectal carcinoma, who are between the age of 18
and 50 years, and have or will undergo surgery for this
condition. The analysis involves pathological review
and MSI status of the tumor, and evaluation of
prognostic significance of family history and MSI status.
Division of Surgical Research – Research Projects
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Topic: Tissue Study – Breast Cancer
Sponsor: Celera Genomics, Inc
Start/End Date: 10-04 - 10-05
Total $2550 per pt, n=40
Investigators: Kelly (PI) Teal (Co-PI), Schwartz
(Pathologist) Drenon
This is a tissue study to obtain breast cancer specimens
for proteomic analysis. The objective is to define
molecular protein targets, present in cancer tissue and
absent in the normal, adjacent tissue.
Collaboration:
GWU/Celera Genomics
New diagnostic tests that provide information to
physicians and patients that can be acted upon
New therapies to intervene in disease development
Therapies intended to address the needs of specific
patient populations
Improving the odds that a potential drug candidate will
pass clinical testing and approval processes.
Proteomics
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Celera Genomics is using industrial-scale
proteomics to evaluate cell surface proteins
from normal and diseased tissues and cell
lines. Findings are then used in an effort to
identify candidate therapeutic targets for
antibodies or small molecules. We do this by
employing proprietary techniques to capture
cell surface proteins and then by identifying
and quantifying the proteins. Cell surface
proteins are believed to represent the most
promising targets for antibody therapeutics
as near-term drug candidates.
Mass Spectrometry
Mass spectrometry is the technique of choice for
identifying proteins of interest. In MS, the sample is
first ionized, and the ions that are formed are
measured by the mass spectrometer. This produces a
mass spectrum, which enables scientists to
determine the identity and quantity of the original
protein by mass. Molecular weight and additional
structural information may be obtained. It is a very
sensitive technical capable of analysis at the parts
per billion levels. For GWU studies, the intent is to
determine the differential of proteins in tumor
compared to normal tissue.
ABI Voyager-DE™
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Celera has identified and validated differentially
expressed proteins on the surface of cancer cells.
Proteins that over-expressed on diseased cells relative
to healthy cells may represent targets for therapeutic
antibodies or small molecule drugs.
Pancreatic Cancer
Identified over 110 differentially expressed cell
surface proteins. Selected 25 proteins for validation
as targets for antibodies and small molecules.
Non-small Cell Lung Cancer
Processing tumor and normal tissue to identify
differentially expressed proteins. Identified
approximately 100 differentially expressed
cell surface proteins.
Colon Cancer
Processing tumor and normal tissue to identify
differentially expressed proteins.
Breast Cancer
Processing tumor and normal tissue to identify
differentially expressed proteins.
Pending Studies
Division of Surgical Research – Pending Research
Projects
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Topic: Retroperitoneal Sarcoma Trail
Sponsor: NIH/ACOSOG
Start/End Date: (pending approval) 3-05 –
Total $ 2K per pt, n=5
Investigators: Hafner (PI), Schwartz, Harisiadis, Carter, Drenon
Title: A Phase III Randomized Study of Preoperative Radiation Plus
Surgery Versus Surgery Alone for Patients with Retroperitoneal
Sarcoma.
This trial will evaluate whether preoperative radiotherapy of 45.050.4 Gy plus surgery improves the progression free survival
compared to surgery alone.
Division of Surgical Research – Pending Research
Projects
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Topic: PPAR receptors in Obesity
Sponsor: McCormick Grant, GWU
Start/End Date: pending approval
Total $ 15K
Investigators: Carter (PI), Brody, Pinzone
TITLE: ANALYSIS OF GASTROINTESTINAL SPECIMENS.
Collection of tissue and blood from patients with a diagnosis of
obesity and gastroparesis,(nerve damage to the stomach)
who are undergoing surgery for these conditions. The
analyses will involve gene and protein studies and is
designed to develop a better understanding of the disease
pathways.
Division of Surgical Research – Pending Research
Projects
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Topic: Factor VII Trauma Study
Sponsor: NovoNordisk
Start/End Date: (pending approval) 6-05 –
Total $ ?
Investigators: Abell (PI), Silva (Co-PI), Carter, Drenon
Title: A Phase II Multi-center, Randomized Double-Blind
Parallel Group, Placebo-controlled Trial to Evaluate the
Efficacy and Safety of Activated Recombinant Factor
VII in the Treatment of Refractory Bleeding in Severely
Injured Trauma Subjects.
Division of Surgical Research – Pending Research
Projects
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Topic: Ointment for Hemorrhoids
Sponsor: Novartis
Start/End Date: (pending approval) 6-05 –
Total $ ?
Investigators: Abell (PI), Silva (Co-PI), Carter, Drenon
Title: A Phase IIb Multi-center, Randomized InvestigatorBlind Parallel Group, Placebo-controlled Trial to
Evaluate the Efficacy and Safety of Iferanserin
(ointment) in Patients with Mild to Moderate
Symptomatic Hemorrhoids.
Division of Surgical Research – Pending Research
Projects
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Topic: IV Antibiotic for Intra-abdominal Infections
Sponsor: Wyeth
Start/End Date: (pending approval) 6-05 –
Total $ ?
Investigators: Brody, Orkin, Katz, Carter, Drenon
Title: A Phase IV Multi-center, Randomized InvestigatorBlind Parallel Group, Placebo-controlled Trial to
Evaluate the Efficacy and Safety of Tigecycline in
Patients with Intra-abdominal Infections.
Current Educational Initiatives
Division of Surgical Research –Educational
Initiatives
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Topic: Educational Grant for Laparascopic Tech.
Sponsor: Ethicon Endo-Surgery, Inc.
Start/End Date: 2-04 – 2-06
Total $ 641K
Investigators: Giordano (PI), Carter, Li
This is an educational grant to support the Washington
Institute for Surgical Endoscopy (WISE) laboratory for
use by medical students, residents and other
physicians interested in learning/improving assorted
laparascopic surgical techniques. Inanimate and
animate (pig) models are available.
Division of Surgical Research –
Educational Initiatives
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Title: Fundamentals of Conducting Research at GWU
Curriculum: 8-10 Modules, including
– Proposal Development
– Contract Review
– IRB Review
– Presentation to Conferences
– Publication Process, etc
Course taught to Faculty, Medical Students, Surgical
Residents
Current Institutional Initiatives
 Feb
2005
 Message
from Dr.
Skip
Williams
 Goals
for
GWUMC
Provost Perspective:
“Investing Resources and Energy in Goals that Move GWUMC Forward”
“GWUMC is also looking at
funding new academic initiatives that
will produce healthcare leaders for
challenging times. We have launched a
joint obesity initiative to examine the
medical and public health implications
of what is now an epidemic of
overweight Americans. This initiative
will join SMHS and SPHHS along with
our clinical partners at the GW Hospital and Medical Faculty Associates in
examining the problem and looking for
academic, research and clinical care
solutions. We intend to do this with our
outside partners so that this initiative is
not done in a vacuum.”