Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 18, 2014

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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage
IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the
genes in a patient's tumor cells may help doctors select the best treatment for patients that
have certain genetic changes.

PRIMARY OBJECTIVES:

I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to
facilitate accrual to randomized adjuvant studies.

II. To obtain clinically annotated tumor tissue and patient-matched non-malignant
deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and
clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert
with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).

SECONDARY OBJECTIVES:

I. To characterize the natural history of molecularly characterized NSCLC to allow subsequent
development of targeted therapies against genotype-defined subpopulations in the adjuvant and
recurrent settings.

II. To cross-validate local genotyping assays for epidermal growth factor receptor (EGFR) and
anaplastic lymphoma receptor tyrosine kinase (ALK) with a central reference standard.

EXPLORATORY OBJECTIVES:

I. To study the genomic evolution of lung cancers by comparing genomic characteristics at
resection and at recurrence.

II. To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for
potentially eligible patients.

III. To study the clinical significance of circulating tumor DNA within the plasma cell-free
DNA (cfDNA) from early stage lung cancer patients.

OUTLINE:

STEP 1 (SCREENING): Patients undergo collection of blood and tissue samples for EGFR, ALK,
and programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1)/cytotoxic
t-lymphocyte-associated protein 4 (CTLA-4) testing via direct sequencing, fluorescence in
situ hybridization (FISH) and immunohistochemistry (IHC). Patients that have had surgery
prior to pre-registration will submit samples from the previous surgery for testing.

STEP 2 (TREATMENT): Patients with a mutation targeted by one or more of the investigational
drugs used in this study or those without mutations are assigned to 1 of 3 treatment
subprotocols.

A081105: Patients are randomized to 1 of 4 treatment arms.

ARM A (BLINDED ERLOTINIB- CLOSED 06/14/17): Blinded patients receive erlotinib hydrochloride
orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years
in the absence of disease progression or unacceptable toxicity.

ARM B (PLACEBO- CLOSED 06/14/17): Patients receive placebo PO QD on days 1-21. Treatment
repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable
toxicity.

ARM C (UNBLINDED ERLOTINIB): Unblinded patients receive erlotinib hydrochloride PO QD on days
1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression
or unacceptable toxicity.

ARM D (OBSERVATION): Patients (including patients previously randomized to placebo) undergo
observation at least every 6 months for 2 years.

E4512: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive crizotinib PO twice daily (BID) on days 1-21. Treatment repeats every
21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation.

EA5142: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat
every 4 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity.

ARM II: Patients are followed serially with imaging for 1 year.

After completion of study, patients that are not enrolled on either A081105, E4512, or EA5142
are followed up every 6 months for 5 years.

Inclusion Criteria:

- PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:

- For pre-surgical patients

- Suspected diagnosis of resectable non-small cell lung cancer; cancers with a
histology of "adenosquamous" are considered a type of adenocarcinoma and thus a
"nonsquamous" histology; patients with squamous cell carcinoma are eligible only
if the registering site has EA5142 Institutional Review Board (IRB) approved

- Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >=
4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural
invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of
American Joint Committee on Cancer (AJCC) staging will be utilized

- For post-surgical patients

- Completely resected non-small cell lung cancer with negative margins (R0);
patients with squamous cell carcinoma are eligible only if the registering site
has EA5142 IRB approved

- Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm);
Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural
invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of
AJCC staging will be utilized

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this
lung cancer

- No locally advanced or metastatic cancer requiring systemic therapy within 5 years
prior to registration; no secondary primary lung cancer diagnosed concurrently or
within 2 year prior to registration

- No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and
PD-1/PD-L1/CTLA-4

- No patients known to be pregnant or lactating

- Patients who have had local genotyping are eligible, regardless of the local result

- No patients with recurrence of lung cancer after prior resection

- Note: Post-surgical patients should proceed to registration immediately following
preregistration

- PATIENT REGISTRATION ELIGIBILITY CRITERIA:

- Completely resected NSCLC with negative margins (R0); cancers with a histology of
"adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous"
histology; patients with squamous cell carcinoma are eligible only if the registering
site has EA5142 IRB approved

- Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4 cm); Note: IB
tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not
eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be
utilized

- Tissue available for the required analyses (either clinical tissue block or slides and
scrolls)

- In order to allow for time for central genotyping and eligibility for the ALCHEMIST
treatment trial, patients must register within the following eligibility windows,
depending on the adjuvant treatment approach:

- If no adjuvant therapy, register patient within 75 days following surgery

- If adjuvant chemotherapy or radiotherapy only, register patient within 225 days
following surgery

- If adjuvant chemotherapy and radiation, register patient within 285 days
following surgery
We found this trial at
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300 South 6th Avenue
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(610) 988-8000
Principal Investigator: Terrence P. Cescon
Phone: 610-988-9323
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Ian Rabinowitz
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Principal Investigator: Peter Rubin
Phone: 207-626-4855
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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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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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Brian B. Whang
Phone: 773-702-9171
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Brian B. Whang
Phone: 617-667-9925
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Grace K. Dy
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
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802-656-8990
Principal Investigator: Hibba Tul Rehman
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Richard D. Hall
Phone: 434-243-6303
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(626) 256-4673
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Phone: 800-826-4673
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3300 Gallows Road
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(703) 776-4001
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Phone: 703-208-6650
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Philip J. Stella
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4725 North Federal Highway
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(954) 771-8000
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Phone: 954-267-7750
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3551 Roger Brooke Dr
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(210) 916-4141
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Phone: 210-916-4837
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100 Michigan Street Northeast
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616.391.9000
Principal Investigator: Kathleen J. Yost
Phone: 773-702-9171
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2500 N State St
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(601) 984-1000
Principal Investigator: John C. Ruckdeschel
Phone: 601-815-6700
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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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524 South Park Street
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(269) 341-7654
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1800 West Charleston Boulevard
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(702) 383-2000
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Phone: 702-384-0013
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8700 Beverly Blvd # 8211
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(1-800-233-2771)
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Phone: 310-423-8965
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Principal Investigator: Bradley T. Sumrall
Phone: 478-633-2152
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Thomas Ng
Phone: 401-444-1488
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: Sherman Baker
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Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Yuhchyau Chen
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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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Principal Investigator: Preston S. Gable
Phone: 619-532-8712
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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Seattle, Washington 98104
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Rafael Santana-Davila
Phone: 800-804-8824
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Rafael Santana-Davila
Phone: 800-804-8824
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Principal Investigator: Benjamin M. Solomon
Phone: 888-634-7268
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Principal Investigator: Rafael Santana-Davila
Phone: 509-228-1680
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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1000 36th Street
Vero Beach, Florida 32960
Principal Investigator: James M. Grichnik
Phone: 772-563-4673
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808 North 39th Avenue
Yakima, Washington 98902
Principal Investigator: John A. Keech
Phone: 509-574-3535
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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
Principal Investigator: Jeffrey L. Berenberg
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2226 Liliha Street
'Aiea, Hawaii 96701
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'Aiea, Hawaii 96701
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Aberdeen, Washington 98520
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Abilene, Texas 79601
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Adrian, Michigan 49221
Principal Investigator: Rex B. Mowat
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1 Akron General Avenue
Akron, Ohio 44307
Principal Investigator: Esther H. Rehmus
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Albany, Georgia 31701
Principal Investigator: Sharad A. Ghamande
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Albuquerque, New Mexico 87106
Principal Investigator: Yanis Boumber
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Albuquerque, New Mexico 87109
Principal Investigator: Ian Rabinowitz
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Albuquerque, New Mexico 87110
Principal Investigator: Ian Rabinowitz
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Albuquerque, New Mexico 87102
Principal Investigator: Ian Rabinowitz
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Albuquerque, New Mexico 87102
Principal Investigator: Ian Rabinowitz
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Alexandria, Louisiana 71301
Principal Investigator: Marc R. Matrana
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Allentown, Pennsylvania 18103
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Alliance, Ohio 44601
Principal Investigator: Sunitha Vemulapalli
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Alma, Michigan 48801
Principal Investigator: Thomas Y. Regenbogen
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Alpena, Michigan 49707
Principal Investigator: Thomas Y. Regenbogen
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Altamonte Springs, Florida 32701
Principal Investigator: Carlos A. Alemany
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Amarillo, Texas 79106
Principal Investigator: Anita Ravipati
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170 North 1100 East
American Fork, Utah 84003
Principal Investigator: William E. Nibley
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Ames, Iowa 50010
Principal Investigator: Debra M. Prow
Phone: 515-956-4132
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Ames, Iowa 50010
Principal Investigator: Debra M. Prow
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
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Anacortes, Washington 98221
Principal Investigator: Alison K. Conlin
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Anaheim, California 92806
Principal Investigator: Han A. Koh
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Anchorage, Alaska 99504
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Keith S. Lanier
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 98508
Principal Investigator: Alison K. Conlin
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
Principal Investigator: John E. Doster
Phone: 864-512-4651
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Gregory P. Kalemkerian
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Annapolis, Maryland 21401
Principal Investigator: Peter R. Graze
Phone: 443-481-1320
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Principal Investigator: Harish G. Ahuja
Phone: 715-623-9869
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Antioch, California 94531
Principal Investigator: Tatjana Kolevska
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Appleton, Wisconsin 54911
Principal Investigator: Matthias Weiss
Phone: 920-380-1500
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Appleton, Wisconsin 54911
Principal Investigator: Matthias Weiss
Phone: 920-380-1500
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Appleton, Wisconsin 54911
Principal Investigator: Matthias Weiss
Phone: 844-510-3600
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1506 South Oneida Street
Appleton, Wisconsin 54915
Principal Investigator: Kamal K. Abbi
Phone: 920-831-8900
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921 North Oak Park Boulevard
Arroyo Grande, California 93420
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 800-506-2550
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 828-213-4150
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Asheville, North Carolina 28803
Principal Investigator: Raymond Thertulien
Phone: 828-650-8037
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Ashland, Kentucky 41101
Principal Investigator: David K. Goebel
Phone: 888-823-5923
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Ashland, KY
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1625 Maple Lane
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, WI
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Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, WI
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Athens, Georgia 30607
Principal Investigator: Sharad A. Ghamande
Phone: 706-353-5006
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Athens, GA
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Taofeek K. Owonikoko
Phone: 888-946-7447
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Sreekanth C. Reddy
Phone: 404-303-3355
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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Atlanta, Georgia 30322
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-778-1868
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Atlanta, GA
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Atlanta, Georgia 30342
Principal Investigator: Taofeek K. Owonikoko
Phone: 888-823-5923
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Atlanta, GA
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Auburn, California 95602
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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Auburn, CA
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Auburn, California 95603
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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Auburn, CA
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Auburn, Washington 98001
Principal Investigator: John A. Keech
Phone: 253-887-9333
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Auburn, WA
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Augusta, Georgia 30912
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-2388
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Augusta, GA
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Aurora, CO
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
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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Aurora, CO
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Jose M. Pacheco
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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