CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
Status: | Recruiting |
---|---|
Conditions: | Cervical Cancer, Cancer, Cancer, Infectious Disease, Women's Studies, Hematology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Hematology, Immunology / Infectious Diseases, Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | February 9, 2009 |
Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients With a Cytologic Diagnosis of Atypical Glandular Cells (AGC)
This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and
human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical
cells. Studying biomarkers in abnormal cervical cells may improve the ability to find
cervical lesions and plan effective treatment.
human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical
cells. Studying biomarkers in abnormal cervical cells may improve the ability to find
cervical lesions and plan effective treatment.
PRIMARY OBJECTIVES:
I. To examine CA-IX, p16, Ki-67, and mini-chromosome maintenance complex component 2 (MCM2)
expression in liquid-based cytology (LBC) specimens to see which subset of markers can
provide the optimal diagnosis of significant cervical lesions in women in North America with
a cytologic diagnosis of atypical glandular cells (AGC) and a positive test for high risk
human papillomavirus (HPV).
II. To examine high risk HPV, CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens to see
which subset of markers can provide the optimal diagnosis of significant cervical lesions in
women in Japan and Korea (with each country?s cohort analyzed separately) with a cytologic
diagnosis of AGC.
SECONDARY OBJECTIVES:
I. To determine whether the accuracy of diagnosis based on high risk HPV and expression of
CA-IX, p16, Ki-67, and/or MCM2 varies with patient age at enrollment and country of
enrollment.
TERTIARY OBJECTIVES:
I. To assess biomarker expression, loss of heterozygosity, and chromosome gains/losses in
formalin-fixed, paraffin-embedded tissue from the highest grade or most abnormal lesion in
women from North America, Japan, or Korea presenting with a cytologic diagnosis of AGC or
with a cytologic/histologic diagnosis of adenocarcinoma in situ (AIS).
II. To determine CA-IX, p16, Ki67, and MCM2 expression in LBC specimens to see which subset
(or combination) of markers will provide higher sensitivity in the diagnosis of cervical
adenocarcinoma in situ (AIS).
OUTLINE:
Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16,
Ki-67, and MCM2 expression via immunohistochemistry (IHC) and for the presence of high risk
HPV deoxyribonucleic acid (DNA) and HPV genotyping.
I. To examine CA-IX, p16, Ki-67, and mini-chromosome maintenance complex component 2 (MCM2)
expression in liquid-based cytology (LBC) specimens to see which subset of markers can
provide the optimal diagnosis of significant cervical lesions in women in North America with
a cytologic diagnosis of atypical glandular cells (AGC) and a positive test for high risk
human papillomavirus (HPV).
II. To examine high risk HPV, CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens to see
which subset of markers can provide the optimal diagnosis of significant cervical lesions in
women in Japan and Korea (with each country?s cohort analyzed separately) with a cytologic
diagnosis of AGC.
SECONDARY OBJECTIVES:
I. To determine whether the accuracy of diagnosis based on high risk HPV and expression of
CA-IX, p16, Ki-67, and/or MCM2 varies with patient age at enrollment and country of
enrollment.
TERTIARY OBJECTIVES:
I. To assess biomarker expression, loss of heterozygosity, and chromosome gains/losses in
formalin-fixed, paraffin-embedded tissue from the highest grade or most abnormal lesion in
women from North America, Japan, or Korea presenting with a cytologic diagnosis of AGC or
with a cytologic/histologic diagnosis of adenocarcinoma in situ (AIS).
II. To determine CA-IX, p16, Ki67, and MCM2 expression in LBC specimens to see which subset
(or combination) of markers will provide higher sensitivity in the diagnosis of cervical
adenocarcinoma in situ (AIS).
OUTLINE:
Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16,
Ki-67, and MCM2 expression via immunohistochemistry (IHC) and for the presence of high risk
HPV deoxyribonucleic acid (DNA) and HPV genotyping.
Inclusion Criteria:
- Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells [AEC],
atypical endometrial cells [AEmC]) or a cytologic/histologic diagnosis of AIS
documented within the last 6 months who can wait at least one week after the AGC or
AIS diagnosis to have an LBC specimen (i.e., ThinPrep) collected and then receive any
other intervention; acceptable time frame range is 4 days prior to registration to 7
days after registration
- Patients with positive HPV results who are willing to undergo a complete histologic
examination of the uterus and cervix, including the cervical transformation zone,
within 6 months of the AGC or AIS diagnosis (histologic examination includes a loop
electrosurgical excision procedure [LEEP], loop excision of the transformation zone
[LETZ], excisional cone biopsy, or hysterectomy)
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
- Patients who have had a hysterectomy
- History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
- Patients who have previously been treated, or are currently being treated with
radiation therapy or chemotherapy for vaginal or cervical cancer
- Patients who are known to be human immunodeficiency virus (HIV)-positive
- Patients who are pregnant and thought to be at risk for excessive bleeding or preterm
labor if a cone biopsy is performed
We found this trial at
134
sites
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121

Principal Investigator: Richard G. Moore
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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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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2000 E Greenville St
Anderson, South Carolina 29621
Anderson, South Carolina 29621
(864) 512-4640

Principal Investigator: Robert F. Goodlett
Phone: 800-486-5941
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Baton Rouge, Louisiana 70815
Principal Investigator: M. G. Fort
Phone: 412-339-5294
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417

Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000

Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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400 South Clark Street
Butte, Montana 59701
Butte, Montana 59701
406-723-2500

Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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3123 Medical Dr
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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272 Hospital Rd
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
740-779-7500

Principal Investigator: Timothy D. Moore
Phone: 877-779-7585
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Columbus, Ohio 43213
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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Columbus, Ohio 43222
Principal Investigator: Timothy D. Moore
Phone: 614-234-5433
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5100 W Broad St
Columbus, Ohio 43228
Columbus, Ohio 43228
(614) 544-1000

Principal Investigator: Timothy D. Moore
Phone: 614-566-3275
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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810 Jasonway Avenue
Columbus, Ohio 43214
Columbus, Ohio 43214
614/442-3130

Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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3535 Olentangy River Rd
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000

Principal Investigator: Timothy D. Moore
Phone: 614-566-4475
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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111 S Grant Ave
Columbus, Ohio 43215
Columbus, Ohio 43215
(614) 566-9000

Principal Investigator: Timothy D. Moore
Phone: 614-566-4475
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
Columbus, Ohio 43219
(614) 383-6000

Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211

Principal Investigator: Radhika P. Gogoi
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Delaware, Ohio 43015
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
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561 West Central Avenue
Delaware, Ohio 43015
Delaware, Ohio 43015
(740) 615-1000

Principal Investigator: Timothy D. Moore
Phone: 740-615-0227
Delaware Health Center-Grady Cancer Center As the center of healthcare in Delaware County, Grady Memorial...
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561 W. Central Avenue
Delaware, Ohio 43015
Delaware, Ohio 43015
(740) 615-1000

Principal Investigator: Timothy D. Moore
Phone: 740-615-2403
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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1202 East Locust Street
Emmett, Idaho 83617
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Gahanna, Ohio 43230
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
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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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1400 29th Street South
Great Falls, Montana 59405
Great Falls, Montana 59405
406-454-2171

Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
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1 St. Francis Drive
Greenville, South Carolina 29601
Greenville, South Carolina 29601
864-255-1000

Principal Investigator: Robert F. Goodlett
Phone: 800-486-5941
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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80 Seymour St
Hartford, Connecticut 6102
Hartford, Connecticut 6102
(860) 545-5000

Principal Investigator: James S. Hoffman
Phone: 860-224-5660
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hazleton, Pennsylvania 18201
Principal Investigator: Radhika P. Gogoi
Phone: 570-271-5251
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Helena, Montana 59601
Principal Investigator: Benjamin T. Marchello
Phone: 412-339-5294
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Houston, Texas 77030
Principal Investigator: Joseph A. Lucci
Phone: 405-271-8777
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Independence, Missouri 64057
Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
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310 Sunnyview Ln
Kalispell, Montana 59901
Kalispell, Montana 59901
(406) 752-5111

Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Providence Medical Center At Providence Medical Center you will discover quality doctors, innovative technology and...
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Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-2000

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
Kansas City, Missouri 64118
(855) 603-3282

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
Kansas City, Missouri 64132
(816) 276-4000

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Community Howard Regional Health Selecting quality health care services for yourself, a relative or friend...
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401 N Ewing St
Lancaster, Ohio 43130
Lancaster, Ohio 43130
(740) 687-8000

Principal Investigator: Timothy D. Moore
Phone: 740-687-8863
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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3131 La Canada St # 241
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
(702) 693-6870

Principal Investigator: Nicola M. Spirtos
Phone: 412-339-5294
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000

Principal Investigator: Evelyn L. Fleming
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
Lee's Summit, Missouri 64086
(816) 347-5000

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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Lewisburg, Pennsylvania 17837
Principal Investigator: Radhika P. Gogoi
Phone: 570-271-5251
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400 Highland Ave
Lewistown, Pennsylvania 17044
Lewistown, Pennsylvania 17044
(717) 248-5411

Principal Investigator: Radhika P. Gogoi
Phone: 570-271-5251
Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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Liberty, Missouri 64068
Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
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4733 Sunset Blvd
Los Angeles, California 90027
Los Angeles, California 90027
(800) 954-8000

Principal Investigator: Scott E. Lentz
Phone: 800-398-3996
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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Los Angeles, California 90095
Principal Investigator: Robin Farias-Eisner
Phone: 888-798-0719
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Mansfield, Ohio 44903
Principal Investigator: Timothy D. Moore
Phone: 419-526-8018
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401 Matthew St
Marietta, Ohio 45750
Marietta, Ohio 45750
(740) 374-1455

Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Marietta Memorial Hospital We are 2,600 strong and the county
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Marion, Ohio 43302
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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Meridian, Idaho 83642
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
Mishawaka, Indiana 46545
(574) 237-1328

Michiana Hematology Oncology PC-Mishawaka Michiana Hematology Oncology's Advanced Centers for Cancer Care include the largest...
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Missoula, Montana 59801
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Saint Patrick Hospital - Community Hospital St. Patrick Hospital opened in 1873 under the sponsorship...
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
(618) 242-4600

Good Samaritan Regional Health Center St. Mary's Good Samaritan, Incorporated (SMGSI) was created in 1996...
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
Mount Vernon, Ohio 43050
(740) 393-9000

Principal Investigator: Timothy D. Moore
Phone: 740-393-9000
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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1512 12th Avenue Road
Nampa, Idaho 83686
Nampa, Idaho 83686
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Nashua, New Hampshire 03063
Principal Investigator: Evelyn L. Fleming
Phone: 603-577-4282
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100 Grand St
New Britain, Connecticut 06050
New Britain, Connecticut 06050
(860) 224-5011

Principal Investigator: James S. Hoffman
Phone: 860-224-5660
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
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254 Easton Ave
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
(732) 745-8600

Principal Investigator: Joyce Varughese
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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New York, New York 10032
Principal Investigator: Jason D. Wright
Phone: 212-305-6361
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Newark, Ohio 43055
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
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1320 W Main St
Newark, Ohio 43055
Newark, Ohio 43055
(740) 348-4000

Principal Investigator: Timothy D. Moore
Phone: 740-348-4000
Licking Memorial Hospital Licking Memorial Health Systems (LMHS) is a not-for-profit health care organization dedicated...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458

Principal Investigator: Katherine M. Moxley
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Emile St
Omaha, Nebraska 68198
Omaha, Nebraska 68198
(402) 559-4000

Principal Investigator: Kerry J. Rodabaugh
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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351 Southwest 9th Street
Ontario, Oregon 97914
Ontario, Oregon 97914
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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1100 West Stewart Drive
Orange, California 92868
Orange, California 92868
Principal Investigator: Shu-Yuan Liao
Phone: 714-734-6220
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Orange, California 92868
Principal Investigator: Krishnansu S. Tewari
Phone: 562-933-0900
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5721 W 119th St
Overland Park, Kansas 66209
Overland Park, Kansas 66209
(913) 498-6000

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
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12300 Metcalf Ave
Overland Park, Kansas 66213
Overland Park, Kansas 66213
(913) 317-7000

Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Saint Luke's South Hospital Saint Luke's South Hospital is a comprehensive health care facility serving...
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3401 N Broad St
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania
(215) 707-2000

Principal Investigator: Enrique Hernandez
Phone: 215-728-2983
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Pinehurst, North Carolina 28374
Principal Investigator: John W. Byron
Phone: 910-715-3500
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Michiana Hematology Oncology In 1968, medical oncologist Thomas Troeger, MD had a dream to advance...
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1805 27th St
Portsmouth, Ohio 45662
Portsmouth, Ohio 45662
(740) 356-5000

Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
Southern Ohio Medical Center Southern Ohio Medical Center (SOMC) is a 222-bed 501(C)(3) not-for-profit hospital...
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Post Falls, Idaho 83854
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Providence, Rhode Island 02905
Principal Investigator: Katina M. Robison
Phone: 401-274-1122
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