Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Breast Subjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Lung Subjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Colorectal Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Prostate Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Bladder Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Uterine Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Kidney & Renal Pelvis Subjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Pancreatic Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Liver Subjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Stomach Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Ovarian Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Esophageal Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. | Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment. |
Outcome Measures
Primary Outcome Measures
- Biomarker Evaluation [Point in time (one day) blood collection at enrollment]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is male or female > 18 years of age.
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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 pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.
- 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:
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Prior or concurrent cancer diagnosis defined as:
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Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
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Recurrence of the same primary cancer within any timeframe; OR
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Concurrent diagnosis of multiple primary cancers
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Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
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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.
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Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
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Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
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IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic Hospital | Phoenix | Arizona | United States | 85054 |
2 | Scottsdale Medical Imaging Research | Scottsdale | Arizona | United States | 85258 |
3 | Arizona Clinical Research Center, Inc. | Tucson | Arizona | United States | 85715 |
4 | Urological Associates of Southern Arizona, PC | Tucson | Arizona | United States | 85741 |
5 | Mercy Research-Fort Smith | Fort Smith | Arkansas | United States | 72903 |
6 | Genesis Cancer Center | Hot Springs | Arkansas | United States | 71913 |
7 | NEA Fowler Family Center for Cancer Care | Jonesboro | Arkansas | United States | 72401 |
8 | CARTI Cancer Center | Little Rock | Arkansas | United States | 72205 |
9 | John Muir Clinical Research | Concord | California | United States | 94520 |
10 | Marin Cancer Care | Greenbrae | California | United States | 94904 |
11 | Alliance Research Centers | Laguna Hills | California | United States | 92653 |
12 | Office of John Homan, MD | Newport Beach | California | United States | 92663 |
13 | North County Oncology | Oceanside | California | United States | 92056 |
14 | UCI Department of Urology | Orange | California | United States | 92868 |
15 | Adventist Health - Saint Helena Hospital | Saint Helena | California | United States | 94574 |
16 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
17 | St. Joseph Heritage Healthcare | Santa Rosa | California | United States | 95403 |
18 | Innovative Clinical Research Institute | Whittier | California | United States | 90603 |
19 | RMR VA Medical Center | Aurora | Colorado | United States | 80045 |
20 | The Urology Center of Colorado | Denver | Colorado | United States | 80211 |
21 | Middlesex Hospital | Middletown | Connecticut | United States | 06457 |
22 | Easter Ct Hematology and Oncology | Norwich | Connecticut | United States | 06360 |
23 | Stamford Hospital | Stamford | Connecticut | United States | 06904 |
24 | Southeast Florida Hematology-Oncology Group, PA | Fort Lauderdale | Florida | United States | 33308 |
25 | CSNF - Central Business Office | Jacksonville | Florida | United States | 32256 |
26 | Jupiter Medical Center | Jupiter | Florida | United States | 33458 |
27 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
28 | Mid Florida Hematology and Oncology Center | Orange City | Florida | United States | 32763 |
29 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34203 |
30 | University Cancer & Blood Center, LLC | Athens | Georgia | United States | 30607 |
31 | Piedmont Cancer Institute, PC | Atlanta | Georgia | United States | 30318 |
32 | Candler Hospital | Savannah | Georgia | United States | 31405 |
33 | Lewis Hall Singletary Oncology Center | Thomasville | Georgia | United States | 31792 |
34 | John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | United States | 60612 |
35 | PMG Research of DuPage Medical Group | Downers Grove | Illinois | United States | 60515 |
36 | Presence Cancer Care / JOHA | Joliet | Illinois | United States | 60435 |
37 | Illinois CancerCare, P.C. | Peoria | Illinois | United States | 61615 |
38 | Orchard Healthcare Reasearch Inc | Skokie | Illinois | United States | 60077 |
39 | SIU School of Medicine | Springfield | Illinois | United States | 62702 |
40 | Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana | United States | 46260 |
41 | PMG Research of McFarland Clinic | Ames | Iowa | United States | 50010 |
42 | Des Moines Oncology Research Associate | Des Moines | Iowa | United States | 50309 |
43 | Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research | Edgewood | Kentucky | United States | 41017 |
44 | Baptist Health-Lexington | Lexington | Kentucky | United States | 40503 |
45 | Norton Cancer Institute-Pavilion | Louisville | Kentucky | United States | 40202 |
46 | Baptist Health | Louisville | Kentucky | United States | 40207 |
47 | Baptist Health- Paducah | Paducah | Kentucky | United States | 42001 |
48 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 68506 |
49 | Holy Cross Hospital Resource Center Department of Cancer Research | Silver Spring | Maryland | United States | 20902 |
50 | Beverly Hospital, Oncology | Beverly | Massachusetts | United States | 01915 |
51 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
52 | Lowell General Hospital | Lowell | Massachusetts | United States | 01854 |
53 | Cancer and Hematology Centers of Western Michigan, PC | Grand Rapids | Michigan | United States | 49503 |
54 | Cancer Research Consortium of West Michigan (CRCWM) | Grand Rapids | Michigan | United States | 49503 |
55 | Ascension Providence Hospitals | Southfield | Michigan | United States | 48075 |
56 | Metro-Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota | United States | 55416 |
57 | Park Nicollet Institute - Oncology Research | Saint Louis Park | Minnesota | United States | 55426 |
58 | St. Dominic's Gynecologic Oncology | Jackson | Mississippi | United States | 39216 |
59 | North Mississippi Medical Center Hematology and Oncology | Tupelo | Mississippi | United States | 38801 |
60 | Mercy Cancer Center | Joplin | Missouri | United States | 64804 |
61 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
62 | Mercy Hospital | Saint Louis | Missouri | United States | 63141 |
63 | Mercy Cancer and Hematology Clinic | Springfield | Missouri | United States | 65804 |
64 | Nebraska Hematology-Oncology -- Lincoln | Lincoln | Nebraska | United States | 68506 |
65 | Somnos Laboratories, Inc. | Lincoln | Nebraska | United States | 68510 |
66 | Cancer Care Specialists | Reno | Nevada | United States | 89519 |
67 | The Minniti Center for Hematology and Oncology | Mickleton | New Jersey | United States | 08056 |
68 | Riverview Medical Center | Red Bank | New Jersey | United States | 07701 |
69 | Albany Medical College | Albany | New York | United States | 12208 |
70 | Brooklyn Urology Research Group | Brooklyn | New York | United States | 11201 |
71 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
72 | Hematology Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
73 | Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | United States | 12601 |
74 | Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division | Poughkeepsie | New York | United States | 12601 |
75 | Richmond University Medical Center | Staten Island | New York | United States | 10310 |
76 | Stony Brook Cancer Center | Stony Brook | New York | United States | 11794 |
77 | Associated Medical Professionals | Syracuse | New York | United States | 13210 |
78 | Cone Health Cancer Center | Greensboro | North Carolina | United States | 27403 |
79 | PMG Research of Hickory, LLC | Hickory | North Carolina | United States | 28601 |
80 | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
81 | PMG Research of Rocky Mount | Rocky Mount | North Carolina | United States | 27804 |
82 | PMG Research of Piedmont | Statesville | North Carolina | United States | 28625 |
83 | Marion L. Shepard Cancer Center | Washington | North Carolina | United States | 27889 |
84 | Zimmer Cancer Center | Wilmington | North Carolina | United States | 28402 |
85 | Hematology & Oncology Associates, Inc. | Canton | Ohio | United States | 44708 |
86 | Tri-County Hematology & Oncology Associates, Inc. | Massillon | Ohio | United States | 44646 |
87 | Cancer Centers of Southwest Oklahoma | Lawton | Oklahoma | United States | 73505 |
88 | Genie Jackson Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
89 | Mercy Oncology Research | Oklahoma City | Oklahoma | United States | 73120 |
90 | St. Luke's University Health Network | Bethlehem | Pennsylvania | United States | 18015 |
91 | Women & Infants Hospital | Providence | Rhode Island | United States | 02905 |
92 | Charleston Cancer Center | Charleston | South Carolina | United States | 29406 |
93 | McLeod Center for Cancer Treatment and Research | Florence | South Carolina | United States | 29506 |
94 | Saint Francis Cancer Center Research Department | Greenville | South Carolina | United States | 29607 |
95 | Lowcountry Urology/PMG Research of Charleston, LLC | North Charleston | South Carolina | United States | 29406 |
96 | Spartanburg Medical Center: Gibbs Cancer Center & Research Institute | Spartanburg | South Carolina | United States | 29303 |
97 | Lexington Medical Center | West Columbia | South Carolina | United States | 29169 |
98 | RH Clinical Research | Rapid City | South Dakota | United States | 57701 |
99 | PMG Research of Bristol, LLC | Bristol | Tennessee | United States | 37620 |
100 | The Jackson Clinic | Jackson | Tennessee | United States | 38301 |
101 | Christus Spohn Cancer Center | Corpus Christi | Texas | United States | 78404 |
102 | University of Texas Health Science Center | Houston | Texas | United States | 77030 |
103 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
104 | San Antonio Military Medical Center | San Antonio | Texas | United States | 78234 |
105 | Cancer Treatment Center | Texarkana | Texas | United States | 75503 |
106 | Renovatio Clinical | The Woodlands | Texas | United States | 77380 |
107 | Community Cancer Trials of Utah | Ogden | Utah | United States | 84405 |
108 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
109 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
110 | Urology of Virginia, PLLC | Virginia Beach | Virginia | United States | 23462 |
111 | Seattle Urology Research Center | Burien | Washington | United States | 98166 |
112 | MultiCare Regional Cancer Center | Tacoma | Washington | United States | 98405 |
113 | CAMC Clinical Trials Center | Charleston | West Virginia | United States | 25304 |
114 | Mon Health Medical Center | Morgantown | West Virginia | United States | 26505 |
115 | West Virginia University Cancer Institute | Morgantown | West Virginia | United States | 26506 |
116 | HSHS St. Vincent Hospital | Green Bay | Wisconsin | United States | 54301 |
117 | Michael Berry Building-Oncology | Janesville | Wisconsin | United States | 53548 |
118 | UW Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
119 | ProHealth Care Research Institute | Waukesha | Wisconsin | United States | 53188 |
Sponsors and Collaborators
- Exact Sciences Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-01