Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/7/2019 |
Start Date: | August 1, 2018 |
End Date: | January 2022 |
Contact: | Marie Wood, MD |
Email: | marie.wood@uvm.edu |
Phone: | 802-656-5452 |
Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion Study to Alliance Study A011502
This phase III trial evaluates mammographic breast density in participants with hormone
receptor-negative breast cancer enrolled on study A011502. High breast density has been shown
to be a strong risk factor for developing breast cancer and decreasing breast density may
decrease the risk for breast cancer. Participants treated with aspirin may show reduced
breast density on a mammogram.
receptor-negative breast cancer enrolled on study A011502. High breast density has been shown
to be a strong risk factor for developing breast cancer and decreasing breast density may
decrease the risk for breast cancer. Participants treated with aspirin may show reduced
breast density on a mammogram.
PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral
(unaffected) breast between the aspirin and placebo arms in patients with hormone receptor
negative breast cancer enrolled in A011502.
SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the
contralateral (unaffected) breast between the aspirin and placebo arms in patients with
hormone receptor negative breast cancer enrolled in A011502.
OUTLINE:
Participants provide bilateral screening mammogram taken prior to all cancer treatment and
within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as
possible to 1 year post-registration to A011502 and as near as possible to 2 years
post-registration to A011502. Participants also undergo collection of blood sample and
menstrual cycle data within 2 weeks after registration and at 1 and 2 years after
registration to A011502.
After completion of study, participants are followed up annually until 10 years from
registration to study A011502.
(unaffected) breast between the aspirin and placebo arms in patients with hormone receptor
negative breast cancer enrolled in A011502.
SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the
contralateral (unaffected) breast between the aspirin and placebo arms in patients with
hormone receptor negative breast cancer enrolled in A011502.
OUTLINE:
Participants provide bilateral screening mammogram taken prior to all cancer treatment and
within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as
possible to 1 year post-registration to A011502 and as near as possible to 2 years
post-registration to A011502. Participants also undergo collection of blood sample and
menstrual cycle data within 2 weeks after registration and at 1 and 2 years after
registration to A011502.
After completion of study, participants are followed up annually until 10 years from
registration to study A011502.
Inclusion Criteria:
- Must be concurrently enrolling to Alliance A011502. Eligible patients may be either
pre- or post-menopausal.
- Patients must have hormone receptor-negative breast cancer.
- Patients must have baseline breast density measurement as defined by one of the
following:
- >= 25% breast density, or
- Scattered areas of fibroglandular density, or
- Breast composition category b, c, or d, per Breast Imaging Reporting and Data
System (BI-RADS) 2013.
- Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views)
taken within 8 weeks prior to registration must be available for submission.
* If baseline mammogram within 8 weeks is not available, a new screening mammogram
must be performed prior to treatment on Alliance A011502. To receive reimbursement for
the cost of this additional mammogram, institutions may submit the A211601
Reimbursement Form, which is available on the Alliance and Cancer Trials Support Unit
(CTSU) web pages.
- Patients receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not
eligible.
- Contralateral unaffected breast in place (with no prior cancer or radiation, no
implants and no plan for breast surgery on contralateral breast over the course of the
study). Patients with a prior biopsy on the unaffected breast are eligible.
- Not pregnant and not nursing.
We found this trial at
254
sites
Honolulu, Hawaii 96817
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-531-8521
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1 South Prospect Street
Burlington, Vermont 05401
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Marie E. Wood
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-539-2273
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-487-7447
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-486-6000
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2226 Liliha Street
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-678-9000
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anaheim, California 92806
Principal Investigator: Jonathan A. Polikoff
Phone: 800-398-3996
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364 White Oak St
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
(336) 625-5151
![Randolph Hospital](/wp-content/uploads/logos/randolph-hospital.png)
Principal Investigator: Vinay K. Gudena
Phone: 336-832-0836
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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1625 Maple Lane
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Auburn, New York 13021
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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1501 S Potomac St
Aurora, Colorado 80012
Aurora, Colorado 80012
(303) 695-2600
![Medical Center of Aurora](/wp-content/uploads/logos/medical-center-of-aurora.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200
![Rush - Copley Medical Center](/wp-content/uploads/logos/rush---copley-medical-center.png)
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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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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Baldwin Park, California 91706
Principal Investigator: Jonathan A. Polikoff
Phone: 800-398-3996
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489 State St
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7000
![Eastern Maine Medical Center](/wp-content/uploads/logos/eastern-maine-medical-center.png)
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bellflower, California 90706
Principal Investigator: Jonathan A. Polikoff
Phone: 800-398-3996
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
![Strecker Cancer Center-Belpre](/wp-content/uploads/logos/strecker-cancer-center-belpre.jpg)
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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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Berlin, Vermont 05602
Principal Investigator: Marie E. Wood
Phone: 802-225-5400
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Billings, Montana 59102
Principal Investigator: Keren Sturtz
Phone: 800-648-6274
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
![Saint Vincent Healthcare](/wp-content/uploads/logos/saint-vincent-healthcare.png)
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
![Sanford Bismarck Medical Center](/wp-content/uploads/logos/sanford-bismarck-medical-center.jpg)
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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1100 Balsam Ave
Boulder, Colorado 80304
Boulder, Colorado 80304
(303) 440-2273
![Boulder Community Hospital](/wp-content/uploads/logos/boulder-community-hospital.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
![Bozeman Deaconess Hospital](/wp-content/uploads/logos/bozeman-deaconess-hospital.jpg)
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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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 773-702-9171
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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Burlington, North Carolina 27216
Principal Investigator: Vinay K. Gudena
Phone: 336-538-7725
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Burlington, Vermont 05405
Principal Investigator: Marie E. Wood
Phone: 802-656-4101
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
(952) 892-2000
![Fairview Ridges Hospital](/wp-content/uploads/logos/fairview-ridges-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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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](/wp-content/uploads/logos/saint-james-community-hospital-and-cancer-treatment-center.png)
Principal Investigator: Keren Sturtz
Phone: 406-723-2621
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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2600 Sixth St. SW
Canton, Ohio 44710
Canton, Ohio 44710
330.363.4908
![Aultman Health Foundation](/wp-content/uploads/logos/aultman-health-foundation.gif)
Principal Investigator: Sunitha Vemulapalli
Phone: 330-363-7274
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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Cary, North Carolina 27511
Principal Investigator: Mark L. Graham
Phone: 919-233-8585
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-363-2690
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Cheyenne, Wyoming 82001
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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1200 West Harrison Stree
Chicago, Illinois 60607
Chicago, Illinois 60607
(312) 996-4350
![Univ of Illinois](/wp-content/uploads/logos/univ-of-illinois.jpg)
Principal Investigator: Kent F. Hoskins
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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272 Hospital Rd
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
740-779-7500
![Adena Regional Medical Center](/wp-content/uploads/logos/adena-regional-medical-center.jpg)
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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12961 27th Ave
Chippewa Falls, Wisconsin 54729
Chippewa Falls, Wisconsin 54729
715-738-3700
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Principal Investigator: Arlene A. Gayle
Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Clinton, South Carolina 29325
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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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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1400 West 4th Street
Coffeyville, Kansas 67337
Coffeyville, Kansas 67337
Principal Investigator: Kelsey E. Larson
Phone: 620-252-1606
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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
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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
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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
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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
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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
![The Mark H. Zangmeister Center](/wp-content/uploads/logos/the-mark-h-zangmeister-center.jpg)
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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Concord, New Hampshire 03301
Principal Investigator: Douglas J. Weckstein
Phone: 603-224-2556
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
![Mercy Hospital](/wp-content/uploads/logos/mercy-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Danville, Illinois 61832
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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115 10th Avenue Northeast
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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561 West Central Avenue
Delaware, Ohio 43015
Delaware, Ohio 43015
(740) 615-1000
![Delaware Health Center-Grady Cancer Center](/wp-content/uploads/logos/delaware-health-center-grady-cancer-center.jpg)
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
![Grady Memorial Hospital](/wp-content/uploads/logos/grady-memorial-hospital.jpg)
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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777 Bannock St
Denver, Colorado 80204
Denver, Colorado 80204
(303) 436-6000
![Denver Health Medical Center](/wp-content/uploads/logos/denver-health-medical-center.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Denver, Colorado 80206
Principal Investigator: Keren Sturtz
Phone: 877-225-5654
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3773 Chry Crk North Dr # 101
Denver, Colorado 80209
Denver, Colorado 80209
Principal Investigator: Keren Sturtz
Phone: 773-702-9171
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80220
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80220
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
![Colorado Blood Cancer Institute](/wp-content/uploads/logos/colorado-blood-cancer-institute.png)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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4567 E 9th Ave
Denver, Colorado 80220
Denver, Colorado 80220
(303) 320-2121
![Rose Medical Center](/wp-content/uploads/logos/rose-medical-center.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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1027 Washington Avenue
Detroit Lakes, Minnesota 56501
Detroit Lakes, Minnesota 56501
Principal Investigator: Bret E. Friday
Phone: 773-702-9171
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Easley, South Carolina 29640
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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East Syracuse, New York 13057
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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2200 Craig Road
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Principal Investigator: Arlene A. Gayle
Phone: 800-782-8581
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
![Fairview Southdale Hospital](/wp-content/uploads/logos/fairview-southdale-hospital.gif)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edwards, Colorado 81632
Principal Investigator: Alexander T. Urquhart
Phone: 970-569-7429
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Effingham, Illinois 62401
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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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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Englewood, Colorado 80113
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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501 E. Hampden Ave.
Englewood, Colorado 80113
Englewood, Colorado 80113
303-788-5000
![Swedish Medical Center](/wp-content/uploads/logos/swedish-medical-center.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Fargo, North Dakota 58103
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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1720 South University Drive
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
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801 Broadway North
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
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801 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6175
![Sanford Medical Center-Fargo](/wp-content/uploads/logos/sanford-medical-center-fargo.jpg)
Principal Investigator: Preston D. Steen
Phone: 800-437-4010
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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820 4th St N
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6161
![Sanford Roger Maris Cancer Center](/wp-content/uploads/logos/roger-maris-cancer-center.jpg)
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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Fergus Falls, Minnesota 56537
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Fond Du Lac, Wisconsin 54935
Principal Investigator: Michael W. Jones
Phone: 800-494-2927
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Fontana, California 92335
Principal Investigator: Jonathan A. Polikoff
Phone: 800-398-3996
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Fort Dodge, Iowa 50501
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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900 Hilligoss Boulevard Southeast
Fosston, Minnesota 56542
Fosston, Minnesota 56542
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
![Unity Hospital](/wp-content/uploads/logos/unity-hospital.jpg)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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