Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
1 other identifier
observational
5,133
1 country
119
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Typical duration for all trials
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedSeptember 1, 2022
August 1, 2022
3.6 years
August 30, 2018
August 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biomarker Evaluation
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
Point in time (one day) blood collection at enrollment
Study Arms (12)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Subjects participating in the study will have blood drawn at enrollment.
Eligibility Criteria
Approximately 7500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (119)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Scottsdale Medical Imaging Research
Scottsdale, Arizona, 85258, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
Mercy Research-Fort Smith
Fort Smith, Arkansas, 72903, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
NEA Fowler Family Center for Cancer Care
Jonesboro, Arkansas, 72401, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
John Muir Clinical Research
Concord, California, 94520, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Office of John Homan, MD
Newport Beach, California, 92663, United States
North County Oncology
Oceanside, California, 92056, United States
UCI Department of Urology
Orange, California, 92868, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Adventist Health - Saint Helena Hospital
St. Helena, California, 94574, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
RMR VA Medical Center
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Easter Ct Hematology and Oncology
Norwich, Connecticut, 06360, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
Southeast Florida Hematology-Oncology Group, PA
Fort Lauderdale, Florida, 33308, United States
CSNF - Central Business Office
Jacksonville, Florida, 32256, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34203, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318, United States
Candler Hospital
Savannah, Georgia, 31405, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
PMG Research of DuPage Medical Group
Downers Grove, Illinois, 60515, United States
Presence Cancer Care / JOHA
Joliet, Illinois, 60435, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Orchard Healthcare Reasearch Inc
Skokie, Illinois, 60077, United States
SIU School of Medicine
Springfield, Illinois, 62702, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260, United States
PMG Research of McFarland Clinic
Ames, Iowa, 50010, United States
Des Moines Oncology Research Associate
Des Moines, Iowa, 50309, United States
Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research
Edgewood, Kentucky, 41017, United States
Baptist Health-Lexington
Lexington, Kentucky, 40503, United States
Norton Cancer Institute-Pavilion
Louisville, Kentucky, 40202, United States
Baptist Health
Louisville, Kentucky, 40207, United States
Baptist Health- Paducah
Paducah, Kentucky, 42001, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 68506, United States
Holy Cross Hospital Resource Center Department of Cancer Research
Silver Spring, Maryland, 20902, United States
Beverly Hospital, Oncology
Beverly, Massachusetts, 01915, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Cancer and Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, 49503, United States
Cancer Research Consortium of West Michigan (CRCWM)
Grand Rapids, Michigan, 49503, United States
Ascension Providence Hospitals
Southfield, Michigan, 48075, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota, 55426, United States
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216, United States
North Mississippi Medical Center Hematology and Oncology
Tupelo, Mississippi, 38801, United States
Mercy Cancer Center
Joplin, Missouri, 64804, United States
Mercy Cancer and Hematology Clinic
Springfield, Missouri, 65804, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Nebraska Hematology-Oncology -- Lincoln
Lincoln, Nebraska, 68506, United States
Somnos Laboratories, Inc.
Lincoln, Nebraska, 68510, United States
Cancer Care Specialists
Reno, Nevada, 89519, United States
The Minniti Center for Hematology and Oncology
Mickleton, New Jersey, 08056, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Albany Medical College
Albany, New York, 12208, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11201, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601, United States
Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
Poughkeepsie, New York, 12601, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, 27804, United States
PMG Research of Piedmont
Statesville, North Carolina, 28625, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889, United States
Zimmer Cancer Center
Wilmington, North Carolina, 28402, United States
Hematology & Oncology Associates, Inc.
Canton, Ohio, 44708, United States
Tri-County Hematology & Oncology Associates, Inc.
Massillon, Ohio, 44646, United States
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505, United States
Genie Jackson Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Oncology Research
Oklahoma City, Oklahoma, 73120, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506, United States
Saint Francis Cancer Center Research Department
Greenville, South Carolina, 29607, United States
Lowcountry Urology/PMG Research of Charleston, LLC
North Charleston, South Carolina, 29406, United States
Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
RH Clinical Research
Rapid City, South Dakota, 57701, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
Christus Spohn Cancer Center
Corpus Christi, Texas, 78404, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
San Antonio Military Medical Center
San Antonio, Texas, 78234, United States
Cancer Treatment Center
Texarkana, Texas, 75503, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Seattle Urology Research Center
Burien, Washington, 98166, United States
MultiCare Regional Cancer Center
Tacoma, Washington, 98405, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Mon Health Medical Center
Morgantown, West Virginia, 26505, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506, United States
HSHS St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Michael Berry Building-Oncology
Janesville, Wisconsin, 53548, United States
UW Carbone Cancer Center
Madison, Wisconsin, 53792, United States
ProHealth Care Research Institute
Waukesha, Wisconsin, 53188, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 7, 2018
Study Start
August 23, 2018
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
September 1, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.