Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
- Conditions
- Stomach CancerBreast CancerLung CancerColorectal CancerBladder CancerUterine CancerRenal Pelvis CancerOvarian CancerProstate CancerKidney Cancer
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03662204
- Lead Sponsor
- Exact Sciences Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5133
-
Subject is male or female > 18 years of age.
-
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.
-
Prior or concurrent cancer diagnosis defined as:
- Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
- Recurrence of the same primary cancer within any timeframe; OR
- Concurrent diagnosis of multiple primary cancers
-
Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
-
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.
-
Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
-
Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
-
IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bladder Blood Sample Collection 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. Pancreatic Blood Sample Collection 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. Esophageal Blood Sample Collection 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. Breast Blood Sample Collection 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. Colorectal Blood Sample Collection 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. Ovarian Blood Sample Collection 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. Prostate Blood Sample Collection 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. Kidney & Renal Pelvis Blood Sample Collection 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. Liver Blood Sample Collection 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. Stomach Blood Sample Collection 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. Lung Blood Sample Collection 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. Uterine Blood Sample Collection 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (119)
Orchard Healthcare Reasearch Inc
🇺🇸Skokie, Illinois, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Hematology Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
Hematology & Oncology Associates, Inc.
🇺🇸Canton, Ohio, United States
Lowcountry Urology/PMG Research of Charleston, LLC
🇺🇸North Charleston, South Carolina, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
West Virginia University Cancer Institute
🇺🇸Morgantown, West Virginia, United States
ProHealth Care Research Institute
🇺🇸Waukesha, Wisconsin, United States
Easter Ct Hematology and Oncology
🇺🇸Norwich, Connecticut, United States
Southeast Florida Hematology-Oncology Group, PA
🇺🇸Fort Lauderdale, Florida, United States
Mercy Research-Fort Smith
🇺🇸Fort Smith, Arkansas, United States
North County Oncology
🇺🇸Oceanside, California, United States
NEA Fowler Family Center for Cancer Care
🇺🇸Jonesboro, Arkansas, United States
Marin Cancer Care
🇺🇸Greenbrae, California, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC
🇺🇸Tucson, Arizona, United States
John Muir Clinical Research
🇺🇸Concord, California, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
UCI Department of Urology
🇺🇸Orange, California, United States
Lewis Hall Singletary Oncology Center
🇺🇸Thomasville, Georgia, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Baptist Health- Paducah
🇺🇸Paducah, Kentucky, United States
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States
CSNF - Central Business Office
🇺🇸Jacksonville, Florida, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Middlesex Hospital
🇺🇸Middletown, Connecticut, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Presence Cancer Care / JOHA
🇺🇸Joliet, Illinois, United States
Des Moines Oncology Research Associate
🇺🇸Des Moines, Iowa, United States
Piedmont Cancer Institute, PC
🇺🇸Atlanta, Georgia, United States
Baptist Health-Lexington
🇺🇸Lexington, Kentucky, United States
Cancer Research Consortium of West Michigan (CRCWM)
🇺🇸Grand Rapids, Michigan, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research
🇺🇸Edgewood, Kentucky, United States
Candler Hospital
🇺🇸Savannah, Georgia, United States
Brooklyn Urology Research Group
🇺🇸Brooklyn, New York, United States
Nebraska Hematology-Oncology -- Lincoln
🇺🇸Lincoln, Nebraska, United States
Cancer and Hematology Centers of Western Michigan, PC
🇺🇸Grand Rapids, Michigan, United States
Cancer Care Specialists
🇺🇸Reno, Nevada, United States
Women & Infants Hospital
🇺🇸Providence, Rhode Island, United States
Community Cancer Trials of Utah
🇺🇸Ogden, Utah, United States
The Minniti Center for Hematology and Oncology
🇺🇸Mickleton, New Jersey, United States
PMG Research of DuPage Medical Group
🇺🇸Downers Grove, Illinois, United States
University Cancer & Blood Center, LLC
🇺🇸Athens, Georgia, United States
Holy Cross Hospital Resource Center Department of Cancer Research
🇺🇸Silver Spring, Maryland, United States
Stony Brook Cancer Center
🇺🇸Stony Brook, New York, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
North Mississippi Medical Center Hematology and Oncology
🇺🇸Tupelo, Mississippi, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
🇺🇸Saint Louis Park, Minnesota, United States
Beverly Hospital, Oncology
🇺🇸Beverly, Massachusetts, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
🇺🇸Poughkeepsie, New York, United States
McLeod Center for Cancer Treatment and Research
🇺🇸Florence, South Carolina, United States
PMG Research of Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Tri-County Hematology & Oncology Associates, Inc.
🇺🇸Massillon, Ohio, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
RH Clinical Research
🇺🇸Rapid City, South Dakota, United States
Mercy Cancer and Hematology Clinic
🇺🇸Springfield, Missouri, United States
Park Nicollet Institute - Oncology Research
🇺🇸Saint Louis Park, Minnesota, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Mercy Cancer Center
🇺🇸Joplin, Missouri, United States
Seattle Urology Research Center
🇺🇸Burien, Washington, United States
Somnos Laboratories, Inc.
🇺🇸Lincoln, Nebraska, United States
Associated Medical Professionals
🇺🇸Syracuse, New York, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Saint Francis Cancer Center Research Department
🇺🇸Greenville, South Carolina, United States
PMG Research of Bristol, LLC
🇺🇸Bristol, Tennessee, United States
Michael Berry Building-Oncology
🇺🇸Janesville, Wisconsin, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
HSHS St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
UW Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Scottsdale Medical Imaging Research
🇺🇸Scottsdale, Arizona, United States
Office of John Homan, MD
🇺🇸Newport Beach, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Mid Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
Illinois CancerCare, P.C.
🇺🇸Peoria, Illinois, United States
PMG Research of McFarland Clinic
🇺🇸Ames, Iowa, United States
Ascension Providence Hospitals
🇺🇸Southfield, Michigan, United States
St. Dominic's Gynecologic Oncology
🇺🇸Jackson, Mississippi, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Premier Medical Group of the Hudson Valley PC
🇺🇸Poughkeepsie, New York, United States
PMG Research of Piedmont
🇺🇸Statesville, North Carolina, United States
Marion L. Shepard Cancer Center
🇺🇸Washington, North Carolina, United States
Zimmer Cancer Center
🇺🇸Wilmington, North Carolina, United States
Cancer Centers of Southwest Oklahoma
🇺🇸Lawton, Oklahoma, United States
Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
🇺🇸Spartanburg, South Carolina, United States
Christus Spohn Cancer Center
🇺🇸Corpus Christi, Texas, United States
Mon Health Medical Center
🇺🇸Morgantown, West Virginia, United States
Cancer Treatment Center
🇺🇸Texarkana, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
MultiCare Regional Cancer Center
🇺🇸Tacoma, Washington, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Genie Jackson Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Mercy Oncology Research
🇺🇸Oklahoma City, Oklahoma, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
RMR VA Medical Center
🇺🇸Aurora, Colorado, United States
Adventist Health - Saint Helena Hospital
🇺🇸Saint Helena, California, United States
St. Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Albany Medical College
🇺🇸Albany, New York, United States
Norton Cancer Institute-Pavilion
🇺🇸Louisville, Kentucky, United States
Baptist Health
🇺🇸Louisville, Kentucky, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States