Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Kidney Cancer, Pancreatic Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:August 23, 2018
End Date:December 1, 2020
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com
Phone:608-957-5652

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The primary objective of this study is to obtain de-identified, clinically characterized,
whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay
development.

Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with
any solid tumor. Subjects will have a blood sample collected at enrollment and provide
medical history prior to initiation of treatment. There will be no further follow-up.

Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or
esophageal cancer.

OR

Subject has suspicion of a primary malignancy of bladder, kidney/renal pelvis, or
ovarian cancer based on imaging.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
collection.

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
collection.

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
collection.

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
We found this trial at
54
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San Antonio, Texas 78215
Principal Investigator: David C Grant
Phone: 210-227-1289
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Hugh Fisher
Phone: 518-262-8579
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1215 Duff Avenue
Ames, Iowa 50010
Principal Investigator: Srikanth Katragadda
Phone: 336-608-3500
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Atlanta, Georgia 30318
Principal Investigator: Vasileios Assikis
Phone: 678-298-3238
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Principal Investigator: Paul Celano
Phone: 443-849-3122
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Bethlehem, Pennsylvania
Principal Investigator: Nicholas Taylor
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Bristol, Tennessee 37620
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Brooklyn, New York 11215
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Burien, Washington 98166
Principal Investigator: Jeffrey Frankel
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Charleston, South Carolina
Principal Investigator: Charles Holladay
Phone: 843-576-1024
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Charleston, West Virginia 25304
Principal Investigator: Steven Jubelirer
Phone: 304-388-9679
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Concord, California
Principal Investigator: Gigi Chen
Phone: 925-674-2437
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Denver, Colorado 80211
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Phone: 303-762-7154
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Downers Grove, Illinois 60515
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Edgewood, Kentucky 41017
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555 East Cheves Street
Florence, South Carolina 29506
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Greenbrae, California 94904
Principal Investigator: Peter Eisenberg
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Hickory, North Carolina 28602
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Jacksonville, Florida 32256
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Joliet, Illinois 60435
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Laguna Hills, California 92653
Principal Investigator: Kenneth Deck
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Lawton, Oklahoma 73505
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Lincoln, Nebraska 68506
Principal Investigator: Kailash Mosalpuria
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Lincoln, Nebraska 68510
Principal Investigator: John Trapp
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8901 Carti Way
Little Rock, Arkansas 72205
Principal Investigator: Kamal Patel, MD
Phone: 501-906-3012
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Principal Investigator: Richard Zuniga
Phone: 978-788-6518
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
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Middletown, Connecticut 06457
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Morgantown, West Virginia 26505
Principal Investigator: Jamie Lesnock
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North Charleston, South Carolina 29406
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Norwich, Connecticut 06360
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Oceanside, California 92056
Principal Investigator: Warren Paroly
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Ogden, Utah 84405
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2776 Enterprise Rd # 100
Orange City, Florida 32763
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Peoria, Illinois 61615
Principal Investigator: Srinivas Jujjavarapu
Phone: 309-243-3614
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Pinehurst, North Carolina 28374
Principal Investigator: Charles Kuzma
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Poughkeepsie, New York 12601
Principal Investigator: Sunil Khurana
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Evan Goldfischer
Phone: 845-437-5010
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Rapid City, South Dakota 57701
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Reno, Nevada 89511
Principal Investigator: Tejvir Singh
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Rocky Mount, North Carolina 27804
Principal Investigator: Desai Priyank
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Saint Helena, California 94574
Principal Investigator: Gregory Smith
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Saint Louis Park, Minnesota 55426
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Silver Spring, Maryland 20902
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Skokie, Illinois 60077
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Stamford, Connecticut 06904
Principal Investigator: Salvatore Del Prete
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Statesville, North Carolina 28625
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Syracuse, New York 13210
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The Woodlands, Texas 77380
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Thomasville, Georgia 31792
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Tucson, Arizona 85712
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Tucson, Arizona 85715
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Virginia Beach, Virginia 23462
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Washington, North Carolina 27889
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Whittier, California 90603
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