Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2019 |
Start Date: | September 24, 2014 |
End Date: | January 31, 2100 |
Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders
This pilot research trial studies molecular profiling in tissue samples from patients with
cancer who got better with treatment that didn?t work for most other patients with the same
disease. Studying samples of tissue from patients with cancer in the laboratory may help
doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify
biomarkers related to how well patients respond to treatment.
cancer who got better with treatment that didn?t work for most other patients with the same
disease. Studying samples of tissue from patients with cancer in the laboratory may help
doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify
biomarkers related to how well patients respond to treatment.
PRIMARY OBJECTIVES:
I. To identify molecular indicators in malignant tissues from patients who were exceptional
responders on clinical trials or standard systemic treatments using whole exome and/or
targeted deep sequencing, as well as potentially other sequencing and other molecular
characterization methods (if adequate tissue exists).
II. To explore associations between the identified molecular indicators and the putative
mechanism of action of the treatment received by the patient.
III. To test the feasibility of identifying "exceptional responders", obtaining the relevant
tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep
sequencing on these samples.
OUTLINE:
Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted
next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic
acid amounts are available will undergo additional analyses including whole genome
sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing,
promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
I. To identify molecular indicators in malignant tissues from patients who were exceptional
responders on clinical trials or standard systemic treatments using whole exome and/or
targeted deep sequencing, as well as potentially other sequencing and other molecular
characterization methods (if adequate tissue exists).
II. To explore associations between the identified molecular indicators and the putative
mechanism of action of the treatment received by the patient.
III. To test the feasibility of identifying "exceptional responders", obtaining the relevant
tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep
sequencing on these samples.
OUTLINE:
Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted
next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic
acid amounts are available will undergo additional analyses including whole genome
sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing,
promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
Inclusion Criteria:
- Documented exceptional response, defined as patients meeting the following criteria:
- Complete response to a regimen in which complete response is expected in < 10% of
similarly treated patients
- Partial response (PR) > 6 months in a regimen in which PRs > 6 months are
expected in < 10% of patients with similar disease treated with same or similar
regimen
- Complete response (CR) or PR of unusual duration, such that the internal review
committee considers it to be an exceptional response; examples below:
- PR of duration > 3 x the median expected PR duration (in cases where PR is
expected in > 10% of patients with the same disease treated with the same
regimen)
- CR or duration > 3 x the median expected CR duration (in cases where CR may
be seen in > 10% of patients with same disease treated with same regimen)
- The observed duration of CR (or PR) is longer than expected for 90% of
patients with same disease treated with same regimen
- Note: it is not required that the patient be enrolled on a clinical trial when
the exceptional response was observed
- Reports of radiologic scans or other evidence documenting response will be submitted
for review; cases where response is not assessable (e.g. adjuvant treatment) will not
be eligible
- Treatment history must be available, for prior treatment and for the drug to which the
exceptional response occurred
- Patient must meet consent criteria; this requires: (i) current exceptional responder
(ER) consent by a living participant not lost to follow-up, (ii) prior consent for
future research by a participant not known to be deceased, but lost to follow-up, or
(iii) if patient is deceased and did not decline to participate in research at the
time of tissue removal for any tissue that would be used in this study, then no
consent is required
- Tumor sample available that meets study requirements
- Required tumor samples MUST exist and be able to be submitted; investigators wishing
to submit samples must not have made agreements that would prohibit the free use of
data from such samples; the National Cancer Institute (NCI) will provide investigators
with a letter for the collaborator amending their existing agreement to allow for the
case to be submitted
- Tumor tissue from prior to administration of the drug to which the exceptional
response occurred is required; ideally this sample will have been collected just
prior to treatment, but other prior tissue will be considered; tissue may be
fresh frozen or formalin-fixed paraffin embedded
- Tumor tissue amount must be at least a core biopsy, and meet minimum specimen
requirements
- Encouraged: normal tissue sample: (optional): blood or other specimen source for
germline sequencing
- The tumor samples and clinical data submitted to the Exceptional Responders Database
in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate
agreements in place to allow for the submission; the Exceptional Responders Database
can accept clinical data and samples from cases enrolled on a Cancer Therapy
Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on
any clinical trial; if the response occurred on a trial that was not CTEP-sponsored,
there are existing agreements between the submitting site and the pharmaceutical
company; if existing agreements do not allow for the submission of sample and clinical
data, the NCI will provide the investigators with a letter that allows the tissue to
be used for the exceptional responders study if signed by the appropriate
collaborator; the letter modifies the existing agreement to include the CTEP
Intellectual Property (IP) Option language that would allow the case to be submitted
to the Exceptional Responders Database; if the existing agreement cannot be modified
and the letter cannot be signed, the proposed case will not be accepted; Note: as
stated above, the patient does not need to have been enrolled on a clinical trial to
be eligible for the exceptional responders study
Exclusion Criteria:
- Patient's response did not meet criteria for an exceptional response
- Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of
patients
- Patient?s duration of response is not > 3 x expected median length of response
- Response not evaluable or not able to be attributed to systemic treatment (e.g.
adjuvant treatment)
- Patient refused consent for use of tissue for research activities included in the
exceptional responders study
- Tumor sample from prior to the exceptional response is not available, or does not meet
quality metrics
We found this trial at
72
sites
60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul M. Barr
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Vi K. Chiu
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Bethesda, Maryland 20892
Principal Investigator: William L. Dahut
Phone: 800-411-1222
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Charles N. Landen
Phone: 434-243-6322
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
(626) 256-4673
Principal Investigator: Robert W. Chen
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Laura L. Tenner
Phone: 210-450-3800
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Thomas J. Giordano
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia 30322
Principal Investigator: Bassel F. El-Rayes
Phone: 404-489-9164
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Anthony D. Elias
Phone: 970-297-6150
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Bethesda, Maryland 20892
Principal Investigator: William L. Dahut
Phone: 800-411-1222
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Boise, Idaho 83706
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Cedar Rapids, Iowa 52401
Principal Investigator: William P. Fusselman
Phone: 319-297-2900
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Chicago, Illinois 60631
Principal Investigator: Irfan A. Mirza
Phone: 773-792-5116
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Melody A. Cobleigh
Phone: 312-942-5498
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1831 Fifth Avenue
Columbus, Georgia 31904
Columbus, Georgia 31904
(706) 320-8700
Principal Investigator: Andrew W. Pippas
Phone: 706-660-6404
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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3535 Olentangy River Rd
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James L. Wade
Phone: 309-243-3605
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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4160 John R St #2122
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Anthony F. Shields
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: James L. Abbruzzese
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Evanston, Illinois 60201
Principal Investigator: Gustavo C. Rodriguez
Phone: 847-570-2109
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1024 S Lemay Ave
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
(970) 495-7000
Principal Investigator: Anthony D. Elias
Phone: 970-297-6150
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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100 Michigan St NE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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1117 29th St S
Great Falls, Montana 59405
Great Falls, Montana 59405
(406) 771-7300
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-679-3966
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-679-3966
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Greenwich, Connecticut 06830
Principal Investigator: Ashwatha Narayana
Phone: 203-863-3698
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Houston, Texas 77030
Principal Investigator: Benjamin L. Musher
Phone: 713-798-1354
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1504 Taub Loop
Houston, Texas 77030
Houston, Texas 77030
(713) 873-2000
Principal Investigator: Benjamin L. Musher
Phone: 713-798-1354
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Kingsport, Tennessee 37660
Principal Investigator: Asheesh Shipstone
Phone: 423-224-5593
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Lawton, Oklahoma 73505
Principal Investigator: Robert S. Mannel
Phone: 405-271-8777
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Howard H. Bailey
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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580 West College Avenue
Marquette, Michigan 49855
Marquette, Michigan 49855
Principal Investigator: Sheetal S. Acharya
Phone: 906-225-4600
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
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Newark, Delaware
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
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Oakland, California 94611
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Robert S. Mannel
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8940 Wood Sage Rd
Peoria, Illinois 61615
Peoria, Illinois 61615
(309) 243-3000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Phoenixville, Pennsylvania 19460
Principal Investigator: Carl W. Sharer
Phone: 610-983-1908
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Portland, Oregon 97227
Principal Investigator: Abdul H. Mansoor
Phone: 503-335-2400
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Portsmouth, New Hampshire 03801
Principal Investigator: Christine Wasilewski
Phone: 603-433-5226
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Richmond, California 94801
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Andrea Wang-Gillam
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3015 North Ballas Road
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
(314) 996-5000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Saint Louis, Missouri 63141
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Ignacio Garrido-Laguna
Phone: 801-581-4477
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Francisco, California 94158
Principal Investigator: Robin K. Kelley
Phone: 877-827-3222
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700 Lawrence Expy
Santa Clara, California 95051
Santa Clara, California 95051
(408) 851-1000
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
Kaiser Permanente Medical Center - Santa Clara At Kaiser Permanente Santa Clara, members and patients...
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Santa Rosa, California 95403
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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Seneca, South Carolina 29672
Principal Investigator: Jeffrey K. Giguere
Phone: 864-679-3966
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1305 W 18th St
Sioux Falls, South Dakota 57117
Sioux Falls, South Dakota 57117
(605) 333-1000
Principal Investigator: Preston D. Steen
Phone: 712-252-0088
Sanford USD Medical Center - Sioux Falls Sanford
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1309 W 17th Street
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
(605) 328-8000
Principal Investigator: Preston D. Steen
Phone: 712-252-0088
Sanford Cancer Center-Oncology Clinic Sanford Health is an integrated health system headquartered in the Dakotas...
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Springfield, Illinois 62703
Principal Investigator: James L. Wade
Phone: 309-243-3605
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1235 E Cherokee St
Springfield, Missouri 65804
Springfield, Missouri 65804
(417) 820-2000
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
Mercy Hospital Springfield We're continuing a tradition of healing more than 120 years old. Mercy...
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3801 South National Avenue
Springfield, Missouri 65807
Springfield, Missouri 65807
(417) 269-6000
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
CoxHealth South Hospital U.S. News & World Report has ranked CoxHealth one of Missouri's best...
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Stockton, California 95210
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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36500 Aurora Dr
Summit, Wisconsin 53066
Summit, Wisconsin 53066
262-434-1000
Principal Investigator: Rubina Qamar
Phone: 414-649-5717
Aurora Medical Center in Summit The Aurora Medical Center in Summit is a state-of-the-art regional...
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Valdosta, Georgia 31602
Principal Investigator: Samuel N. Ofori
Phone: 229-259-4628
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Walnut Creek, California 94596
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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Waukesha, Wisconsin 53188
Principal Investigator: Timothy R. Wassenaar
Phone: 262-928-7632
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West Chester, Pennsylvania 19380
Principal Investigator: William E. Luginbuhl
Phone: 610-431-5297
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300 South 6th Avenue
West Reading, Pennsylvania 19611
West Reading, Pennsylvania 19611
(610) 988-8000
Principal Investigator: Terrence P. Cescon
Phone: 610-988-9323
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Edward A. Levine
Phone: 336-713-6771
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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