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

August 31, 2022 updated by: Exact Sciences Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Medical Imaging Research
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center, Inc.
      • Tucson, Arizona, United States, 85741
        • Urological Associates of Southern Arizona, PC
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Research-Fort Smith
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Jonesboro, Arkansas, United States, 72401
        • NEA Fowler Family Center for Cancer Care
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Concord, California, United States, 94520
        • John Muir Clinical Research
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • Newport Beach, California, United States, 92663
        • Office of John Homan, MD
      • Oceanside, California, United States, 92056
        • North County Oncology
      • Orange, California, United States, 92868
        • UCI Department of Urology
      • Saint Helena, California, United States, 94574
        • Adventist Health - Saint Helena Hospital
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • Santa Rosa, California, United States, 95403
        • St. Joseph Heritage Healthcare
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • RMR VA Medical Center
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital
      • Norwich, Connecticut, United States, 06360
        • Easter Ct Hematology and Oncology
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Southeast Florida Hematology-Oncology Group, PA
      • Jacksonville, Florida, United States, 32256
        • CSNF - Central Business Office
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center
      • Sarasota, Florida, United States, 34203
        • Sarasota Memorial Hospital
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, PC
      • Savannah, Georgia, United States, 31405
        • Candler Hospital
      • Thomasville, Georgia, United States, 31792
        • Lewis Hall Singletary Oncology Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County
      • Downers Grove, Illinois, United States, 60515
        • PMG Research of DuPage Medical Group
      • Joliet, Illinois, United States, 60435
        • Presence Cancer Care / JOHA
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, P.C.
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Reasearch Inc
      • Springfield, Illinois, United States, 62702
        • SIU School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana, LLC
    • Iowa
      • Ames, Iowa, United States, 50010
        • PMG Research of McFarland Clinic
      • Des Moines, Iowa, United States, 50309
        • Des Moines Oncology Research Associate
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research
      • Lexington, Kentucky, United States, 40503
        • Baptist Health-Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute-Pavilion
      • Paducah, Kentucky, United States, 42001
        • Baptist Health- Paducah
    • Maryland
      • Baltimore, Maryland, United States, 68506
        • Greater Baltimore Medical Center
      • Silver Spring, Maryland, United States, 20902
        • Holy Cross Hospital Resource Center Department of Cancer Research
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Beverly Hospital, Oncology
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan, PC
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan (CRCWM)
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospitals
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota Community Oncology Research Consortium (MMCORC)
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute - Oncology Research
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • St. Dominic's Gynecologic Oncology
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center Hematology and Oncology
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Mercy Cancer Center
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Cancer and Hematology Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology -- Lincoln
      • Lincoln, Nebraska, United States, 68510
        • Somnos Laboratories, Inc.
    • Nevada
      • Reno, Nevada, United States, 89519
        • Cancer Care Specialists
    • New Jersey
      • Mickleton, New Jersey, United States, 08056
        • The Minniti Center for Hematology and Oncology
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Brooklyn, New York, United States, 11201
        • Brooklyn Urology Research Group
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley PC
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook Cancer Center
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory, LLC
      • Pinehurst, North Carolina, United States, 28374
        • Firsthealth Moore Regional Hospital
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount
      • Statesville, North Carolina, United States, 28625
        • PMG Research of Piedmont
      • Washington, North Carolina, United States, 27889
        • Marion L. Shepard Cancer Center
      • Wilmington, North Carolina, United States, 28402
        • Zimmer Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44708
        • Hematology & Oncology Associates, Inc.
      • Massillon, Ohio, United States, 44646
        • Tri-County Hematology & Oncology Associates, Inc.
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of Southwest Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Genie Jackson Stephenson Cancer Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Oncology Research
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Florence, South Carolina, United States, 29506
        • McLeod Center for Cancer Treatment and Research
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center Research Department
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Urology/PMG Research of Charleston, LLC
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • RH Clinical Research
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • CHRISTUS Spohn Cancer Center
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78234
        • San Antonio Military Medical Center
      • Texarkana, Texas, United States, 75503
        • Cancer Treatment Center
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Virginia Beach, Virginia, United States, 23462
        • Urology Of Virginia, Pllc
    • Washington
      • Burien, Washington, United States, 98166
        • Seattle Urology Research Center
      • Tacoma, Washington, United States, 98405
        • MultiCare Regional Cancer Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
      • Morgantown, West Virginia, United States, 26505
        • Mon Health Medical Center
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Cancer Institute
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • HSHS St. Vincent Hospital
      • Janesville, Wisconsin, United States, 53548
        • Michael Berry Building-Oncology
      • Madison, Wisconsin, United States, 53792
        • UW Carbone Cancer Center
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Care Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 pancreatic, 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. Prior or concurrent cancer diagnosis defined as:

    1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
    2. Recurrence of the same primary cancer within any timeframe; OR
    3. Concurrent diagnosis of multiple primary 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Evaluation
Time Frame: 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.
Point in time (one day) blood collection at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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