S0820, Adenoma and Second Primary Prevention Trial



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:March 2013
End Date:July 2029
Contact:Patricia N. O'Kane, B.S.
Email:pokane@swog.org
Phone:210-614-8808

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A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be
effective in reducing a three-year event rate of adenomas and second primary colorectal
cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

The purpose of this study is to assess whether the combination of eflornithine 500 mg and
sulindac 150 mg (compared to corresponding placebos) has efficacy against colorectal lesions
with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or
greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or
total colorectal events.

Inclusion Criteria:

- History of Stage 0-III colon or rectal cancer with primary resection 1 year previously

- Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence
of disease

- Must not have cardiovascular risk factors including unstable angina, history of
myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or
NY Heart Assoc Class III or IV heart failure.

- Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190
mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high
blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to
registration

- At least 30 days from completion of adjuvant chemo and RT.

- Presence of gastroesophageal reflux disease acceptable if controlled with medications

- Not receiving or planning to receive concomitant intravenous corticosteroids on a
regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a
regular predictable intermittent basis. NSAID use must not exceed 10 days per month;
Maximum aspirin dose

- 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for
asthma or related conditions) are allowed.

- Able to swallow oral medications

- Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL.
(A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥
3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin ≤ 2.0 mg/dL and AST
(SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN

- Zubrod PS 0-1, 18 years of age or older

- Will not participate in any other clinical trial for the treatment or prevention of
cancer unless off protocol treatment, on follow-up phase only

- Offered opportunity to participate in blood specimen banking

Exclusion Criteria:

- History of colon resection > 40 cm

- Mid-low rectal cancer

- Recurrent or metastatic disease

- High cardiovascular risk; Uncontrolled hypertension

- Planned radiation therapy or additional chemotherapy

- Documented history of gastric/duodenal ulcer within last 12 months and/or current
treatment or active symptoms of gastric/duodenal ulcer

- Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal
cancer, or inflammatory bowel disease

- ≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on
prestudy audiogram

- Known hypersensitivity to sulindac or excipient byproducts. Previous asthma,
urticaria, or allergic-type reaction to aspirin or other NSAIDs

- Significant medical or psychiatric condition that would preclude study completion (8
years)

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for > 5 years

- Pregnant or nursing women. Women/men of reproductive potential must agree to use
effective contraception
We found this trial at
948
sites
601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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1201 Camino de Salud Northeast
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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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Krista E. Evans
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: James W. Fleshman
Phone: 800-422-9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Marwan G. Fakih
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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2500 N State St
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(601) 984-1000
Principal Investigator: Louis V. Puneky
Phone: 601-815-6700
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524 South Park Street
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(269) 341-7654
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Phone: 269-373-7458
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200 North Park Street
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(269) 382-2500
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Phone: 616-391-1230
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1800 West Charleston Boulevard
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(702) 383-2000
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Phone: 702-384-0013
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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529 West Markham Street
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(501) 686-7000
Principal Investigator: Jonathan A. Laryea
Phone: 501-686-8274
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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4805 Northeast Glisan Street
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(503) 215-1111
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Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4502 Medical Drive
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(210) 567-7000
Principal Investigator: Sukeshi P. Arora
Phone: 210-450-3800
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Seattle, Washington 98104
Principal Investigator: Gary E. Goodman
Phone: 206-215-3086
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1100 Fairview Avenue North
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(206) 667-5000
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3900 W Avera Drive
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(605) 322-4700
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808 North 39th Avenue
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Principal Investigator: John A. Keech
Phone: 253-403-2394
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98-1079 Moanalua Road
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Principal Investigator: Jeffrey L. Berenberg
Phone: 808-486-6000
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Aberdeen, Washington 98520
Principal Investigator: Gary E. Goodman
Phone: 360-412-8958
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Abilene, Texas 79601
Principal Investigator: Ke Ning
Phone: 888-823-5923
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Willard G. Andrews
Phone: 215-481-2402
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818 Riverside Ave.
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(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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Principal Investigator: Rex B. Mowat
Phone: 800-444-3561
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Albany, Georgia 31701
Principal Investigator: Chirag R. Jani
Phone: 229-312-0405
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Albuquerque, New Mexico 87110
Principal Investigator: Vi K. Chiu
Phone: 505-559-6113
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Allentown, Pennsylvania 18103
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anacortes, Washington 98221
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Principal Investigator: Han A. Koh
Phone: 800-398-3996
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 206-386-2323
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 98508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
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Phone: 800-486-5941
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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Antigo, Wisconsin 54409
Principal Investigator: Christopher G. Peterson
Phone: 877-405-6866
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Antioch, California 94531
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Auburn, California 95602
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Auburn, California 95603
Principal Investigator: Ari D. Baron
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Auburn, Washington 98001
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Martin D. McCarter
Phone: 720-848-0650
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 206-342-6954
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3325 Pocahontas Road
Baker City, Oregon 97814
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Baldwin Park, California 91706
Principal Investigator: Han A. Koh
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Baltimore, Maryland 21244
Principal Investigator: Leon C. Hwang
Phone: 301-816-7218
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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22 South Greene Street
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410-328-7904
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Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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4305 New Shepherdsville Road
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Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Baton Rouge, Louisiana 70809
Principal Investigator: Robert W. Veith
Phone: 504-568-2428
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Baton Rouge, Louisiana 70809
Principal Investigator: Burke J. Brooks
Phone: 225-761-5346
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Baton Rouge, Louisiana 70809
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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Baton Rouge, Louisiana 70805
Principal Investigator: Augusto C. Ochoa
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Baton Rouge, Louisiana 70816
Principal Investigator: Burke J. Brooks
Phone: 225-761-5346
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bay City, Michigan 48706
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Beachwood, Ohio 44122
Principal Investigator: Jennifer A. Dorth
Phone: 800-641-2422
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Principal Investigator: Majd Chahin
Phone: 843-522-7819
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3535 Pentagon Boulevard
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Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Bel Air, Maryland 21014
Principal Investigator: Yixing Jiang
Phone: 443-643-3010
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 425-688-5407
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Bellflower, California 90706
Principal Investigator: Han A. Koh
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Bellingham, Washington 98225
Principal Investigator: Gary E. Goodman
Phone: 360-715-4133
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Principal Investigator: William J. Charles
Phone: 704-834-2932
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800 Farson Street
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(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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1300 Anne Street NW
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(218) 751-5430
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Bend, Oregon 97701
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Phone: 541-706-2909
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Berkeley, California 94704
Principal Investigator: Ari D. Baron
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Phone: 802-225-5400
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Berwyn, Illinois 60402
Principal Investigator: Irene Q. Ma
Phone: 708-783-0966
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Beverly, Massachusetts 01915
Principal Investigator: Angus P. McIntyre
Phone: 978-283-4000
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Big Rapids, Michigan 49307
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
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Phone: 800-648-6274
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
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1505 Eastland Drive
Bloomington, Illinois 61701
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Bloomington, Illinois 61701
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100 E Idaho St
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(208) 381-2711
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Phone: 907-212-6871
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Boise, Idaho 83706
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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Phone: 303-777-2663
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Boulder, Colorado 80303
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960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
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Phone: 406-969-6060
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