The National Myelodysplastic Syndromes (MDS) Study
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/2/2018 |
Start Date: | April 2016 |
End Date: | September 2021 |
Contact: | Chuck Wagner |
Email: | mdscontact@emmes.com |
The National Myelodysplastic Syndromes Natural History Study
Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic
syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap
disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be
followed long term. Clinical data, blood, and tissue samples will be collected to establish a
biorepository to facilitate the study of the natural history of MDS.
syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap
disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be
followed long term. Clinical data, blood, and tissue samples will be collected to establish a
biorepository to facilitate the study of the natural history of MDS.
Multi-center, prospective cohort study enrolling patients from centers in the National Cancer
Institute (NCI) National Clinical Trials Network (NCTN) and NCI Community Oncology Research
Program (NCORP). The accrual period is 5+ years. After central pathology review of registered
participants, approximately 2,000 cases of MDS or MDS/MPN overlap disorders, and 500 cases of
ICUS will be identified for the longitudinal study cohort and up to 1000 cases will be
identified for the cross-sectional cohort. No more than 3500 total participants will be
registered. Participants in the longitudinal cohort may be followed for life.
The goal of the National MDS Study is to establish a publicly available resource to
facilitate the study of MDS natural history. This will be accomplished through: 1) Creation
of a multi-institutional, longitudinal collection of consistently processed and clinically
well-annotated blood and tissue specimens collected prospectively from participants with MDS
and participants with idiopathic cytopenia of undetermined significance (ICUS); and 2)
Support for investigator-initiated studies of MDS that will have high-impact for MDS
patients, including basic science, clinical, health outcomes and epidemiological research.
Institute (NCI) National Clinical Trials Network (NCTN) and NCI Community Oncology Research
Program (NCORP). The accrual period is 5+ years. After central pathology review of registered
participants, approximately 2,000 cases of MDS or MDS/MPN overlap disorders, and 500 cases of
ICUS will be identified for the longitudinal study cohort and up to 1000 cases will be
identified for the cross-sectional cohort. No more than 3500 total participants will be
registered. Participants in the longitudinal cohort may be followed for life.
The goal of the National MDS Study is to establish a publicly available resource to
facilitate the study of MDS natural history. This will be accomplished through: 1) Creation
of a multi-institutional, longitudinal collection of consistently processed and clinically
well-annotated blood and tissue specimens collected prospectively from participants with MDS
and participants with idiopathic cytopenia of undetermined significance (ICUS); and 2)
Support for investigator-initiated studies of MDS that will have high-impact for MDS
patients, including basic science, clinical, health outcomes and epidemiological research.
Inclusion Criteria:
- Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.)
MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone
marrow assessments, or diagnosed with de novo or therapy-related MDS within 6-months
of enrollment per the World Health Organization (WHO) criteria1 and undergoing
clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate
disease status
- Bone marrow aspirate expected to be performed within 1 week of registration, and in
all cases must be performed no later than 4 weeks after enrollment
- Age 18 or older
- B12 level, serum folate, ferritin, and Thyroid-Stimulating Hormone (TSH) tests
performed in prior 6 months
Exclusion Criteria:
- Prior treatment for MDS at entry and through the time of the entry bone marrow
aspirate
- Treatment with hematopoietic growth factors in prior 6 months
- Diagnosis of a solid tumor or hematologic malignancy within two years prior to
enrollment except for in situ cancer of the skin (basal or squamous cell), cervix,
bladder, breast, or prostate
- Treatment with radiation therapy in the two years prior to registration
- Non-hormonal treatment for malignancy within the two years prior to registration
- Established hereditary bone marrow failure syndrome
- Known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal
hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte
leukemia
- Enrolled in the Connect® MDS/AML Disease Registry (NCT01688011)
We found this trial at
176
sites
505 S Plummer Ave
Chanute, Kansas 66720
Chanute, Kansas 66720
(620) 431-7580
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500
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300 Community Drive
Manhasset, New York 11030
Manhasset, New York 11030
(516) 562-0100
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Principal Investigator: Vincent Vinciguerra, MD
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
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Aberdeen, South Dakota 57401
Principal Investigator: Vinod Parameswaran, MD
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
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Anaheim, California 92806
Principal Investigator: Louis Fehrenbacher, MD
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Baldwin Park, California 91706
Principal Investigator: Louis Fehrenbacher, MD
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
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Bellflower, California 90706
Principal Investigator: Louis Fehrenbacher, MD
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
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Principal Investigator: James Lloyd Wade, MD, FACP, FASCO
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
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Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Bronx, New York 10467
Principal Investigator: Joseph Sparano, MD
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Bronx, New York 10461
Principal Investigator: Joseph Sparano, MD
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Burlington, Wisconsin 53105
Principal Investigator: Thomas Saphner, MD, FACP
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
573-331-3000
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Carbondale, Illinois 62902
Principal Investigator: James Lloyd Wade, MD
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W Wilbur, MD
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Charleston, West Virginia 25304
Principal Investigator: Steven James Jubelirer, MD
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2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
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Principal Investigator: Aaron Gerds, MD
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2500 Metrohealth Dr
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-7800
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Principal Investigator: Bruce Averbrook, MD
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
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Principal Investigator: Joseph Leach, MD
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
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Principal Investigator: Joseph Joe Lukose Vadakara, MD
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Decatur, Illinois 62526
Principal Investigator: James Lloyd Wade, MD
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
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Principal Investigator: James Lloyd Wade, MD
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1200 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-6212
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Principal Investigator: Robert J Behrens, MD
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Des Moines, Iowa 50309
Principal Investigator: Robert J Behrens, MD
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Des Moines, Iowa 50309
Principal Investigator: Robert J Behrens, MD
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2020 Central Ave
Dodge City, Kansas 67801
Dodge City, Kansas 67801
(620) 227-2488
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Duluth, Minnesota 55805
Principal Investigator: Basem Said Goueli, MD, PhD
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Duluth, Minnesota 55805
Principal Investigator: Bret E.B. Friday, MD, PhD
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Duluth, Minnesota 55805
Principal Investigator: Bret E.B. Friday, MD, PhD
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Easley, South Carolina 29640
Principal Investigator: Jeffrey K Giguere, MD
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Effingham, Illinois 62401
Principal Investigator: Kendrith Rowland, MD
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Elk Grove Village, Illinois 60007
Principal Investigator: Bruce Bank, MD
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Elmira, New York 14905
Principal Investigator: William T Muuse, MD, FACP
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18200 Lorain Avenue
Fairview, Ohio 44111
Fairview, Ohio 44111
Principal Investigator: Bruce Averbrook, MD
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Fargo, North Dakota 58122
Principal Investigator: Preston D Steen, MD
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2601 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-2900
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Principal Investigator: Preston D Steen, MD
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801 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6175
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Principal Investigator: Preston D Steen, MD
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Fontana, Wisconsin 54937
Principal Investigator: Thomas Saphner, MD, FACP
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Fort Scott, Kansas 66701
(620) 223-8589
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Principal Investigator: Shaker Dakhil, MD
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
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Principal Investigator: Joseph Leach, MD
Unity Hospital Unity Hospital is one of the Twin Cities
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3315 N Seminary St
Galesburg, Illinois 61401
Galesburg, Illinois 61401
309-344-9269
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Principal Investigator: James Lloyd Wade, MD, FACP, FASCO
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Germantown, Wisconsin 53022
Principal Investigator: Thomas Saphner, MD, FACP
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40 V-Twin Drive
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
(717) 339-2640
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Principal Investigator: Amir Tabatabai, MD
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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Gig Harbor, Washington 98335
Principal Investigator: John A Keech, DO
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Grafton, Wisconsin 53024
Principal Investigator: Thomas Saphner, MD, FACP
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100 Michigan St NE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1774
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Principal Investigator: Kathleen Yost, MD
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
![Benefis Healthcare- Sletten Cancer Institute](/wp-content/uploads/logos/benefis-healthcare--sletten-cancer-institute.gif)
Principal Investigator: Benjamin Marchello, MD
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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835 S Van Buren St
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
(920) 433-0111
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Principal Investigator: Brian L Burnette, MD
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835 S. Van Buren St.
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
(920) 884-3135
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Principal Investigator: Briane Leslie Burnette, MD
Green Bay Oncology at Saint Vincent Hospital We are one of a select few physician...
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
(920) 884-3135
![Green Bay Oncology Limited at Saint Mary's Hospital](/wp-content/uploads/logos/green-bay-oncology-limited-at-saint-mary-s-hospital.jpg)
Principal Investigator: Brian Leslie Burnette, MD
Green Bay Oncology Limited at Saint Mary's Hospital We are one of a select few...
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1726 Shawano Ave
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
(920) 498-4200
![Saint Mary's Hospital](/wp-content/uploads/logos/saint-mary-s-hospital.jpg)
Principal Investigator: Brian L Burnette, MD
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
(920) 288-8000
![Aurora BayCare Medical Center](/wp-content/uploads/logos/aurora-baycare-medical-center.jpg)
Principal Investigator: Thomas Saphner, MD, FACP
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Greenville, South Carolina 29607
Principal Investigator: Robert Siegel, MD, FACP
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1 St. Francis Drive
Greenville, South Carolina 29601
Greenville, South Carolina 29601
864-255-1000
![Saint Francis Hospital](/wp-content/uploads/logos/saint-francis-hospital.jpg)
Principal Investigator: Robert Siegel, MD
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey Giguere, MD
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey Giguere, MD
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Greer, South Carolina 29650
Principal Investigator: Jeffrey Giguere, MD
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Harbor City, California 90710
Principal Investigator: Louis Fehrenbacher, MD
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Hazleton, Pennsylvania 18201
Principal Investigator: Joseph Joe Lukose Vadakara, MD
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1 Salt Creek Lane
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet, MD
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Honolulu, Hawaii 96813
Principal Investigator: Jeffrey L Berenberg, MD
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Honolulu, Hawaii 96813
Principal Investigator: Jeffrey L Berenberg, MD
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1301 Punchbowl St
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
(808) 538-9011
![Queen's Medical Center](/wp-content/uploads/logos/queen-s-medical-center.jpg)
Principal Investigator: Jeffrey L Berenberg, MD
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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800 W. Laurel
Independence, Kansas 67301
Independence, Kansas 67301
620-331-4099
![Cancer Center of Kansas-Independence](/wp-content/uploads/logos/cancer-center-of-kansas-independence.jpg)
Principal Investigator: Shaker Dakhil, MD
Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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Independence, Ohio 44131
Principal Investigator: Bruce Averbrook, MD
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Jacksonville, Florida 32207
Principal Investigator: Edward Gorak, DO, MS, MBA
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
(573) 632-4800
![Capital Region Medical Center-Goldschmidt Cancer Center](/wp-content/uploads/logos/capital-region-medical-center-goldschmidt-cancer-center.jpg)
Principal Investigator: James Wade, MD
Capital Region Medical Center-Goldschmidt Cancer Center At the Goldschmidt Cancer Center in Jefferson City, board...
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117 Harlem Ave
Kankakee, Illinois 60468
Kankakee, Illinois 60468
(708) 258-9754
![Presence Saint Mary's Hospital](/wp-content/uploads/logos/presence-saint-mary-s-hospital.png)
Principal Investigator: Sylvia Velinova Falls, MD
Presence Saint Mary's Hospital Presence St. Mary's, originally known as the Emergency Hospital, was opened...
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Kenosha, Wisconsin 53142
Principal Investigator: Thomas Saphner, MD, FACP
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750 Avenue D West
Kingman, Kansas 67068
Kingman, Kansas 67068
(620) 532-3147
![Cancer Center of Kansas, PA - Kingman](/wp-content/uploads/logos/cancer-center-of-kansas-pa---kingman.jpg)
Principal Investigator: Shaker Dakhil, MD
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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3525 Lakeland Hills Boulevard
Lakeland, Florida 33805
Lakeland, Florida 33805
Principal Investigator: Madhavi Venigalla, MD
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325 Maine Street
Lawrence, Kansas 66044
Lawrence, Kansas 66044
(785) 505-5000
![Lawrence Memorial Hospital](/wp-content/uploads/logos/lawrence-memorial-hospital.png)
Principal Investigator: Shaker Dakhil, MD
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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Lawton, Oklahoma 73505
Principal Investigator: Adam Asch, MD
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