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

Last updated: August 31, 2022
Sponsor: Exact Sciences Corporation
Overall Status: Completed

Phase

N/A

Condition

Liver Cancer

Endometrial Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03662204
2018-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 oresophageal cancer. OR Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renalpelvis, or ovarian cancer based on imaging.
  3. Subject understands the study procedures and is able to provide informed consent toparticipate in the study and authorization for release of relevant protected healthinformation to the study Investigator.

Exclusion

Exclusion Criteria:

  1. Prior or concurrent cancer diagnosis defined as:
  2. Any previous cancer diagnosis within the past 5 years (with the exceptions ofbasal cell or squamous cell skin cancers); OR
  3. Recurrence of the same primary cancer within any timeframe; OR
  4. Concurrent diagnosis of multiple primary cancers
  5. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/samplecollection.
  6. Any treatment for the primary malignancy or sites of metastases. Subject may not havestarted neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy orother treatment and/or surgery prior to blood sample collection.
  7. Less than 3 days between fine needle aspiration (FNA) of target pathology and bloodcollection.
  8. Less than 7 days between biopsy (other than FNA) of target pathology and bloodcollection.
  9. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  10. Individual has a condition the Investigator believes would interfere with his or herability to provide informed consent, comply with the study protocol, which mightconfound the interpretation of the study results or put the person at undue risk.

Study Design

Total Participants: 5133
Study Start date:
August 23, 2018
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Scottsdale Medical Imaging Research

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Mercy Research-Fort Smith

    Fort Smith, Arkansas 72903
    United States

    Site Not Available

  • Genesis Cancer Center

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • NEA Fowler Family Center for Cancer Care

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • John Muir Clinical Research

    Concord, California 94520
    United States

    Site Not Available

  • Marin Cancer Care

    Greenbrae, California 94904
    United States

    Site Not Available

  • Alliance Research Centers

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Office of John Homan, MD

    Newport Beach, California 92663
    United States

    Site Not Available

  • North County Oncology

    Oceanside, California 92056
    United States

    Site Not Available

  • UCI Department of Urology

    Orange, California 92868
    United States

    Site Not Available

  • Adventist Health - Saint Helena Hospital

    Saint Helena, California 94574
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • St. Joseph Heritage Healthcare

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • RMR VA Medical Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • The Urology Center of Colorado

    Denver, Colorado 80211
    United States

    Site Not Available

  • Middlesex Hospital

    Middletown, Connecticut 06457
    United States

    Site Not Available

  • Easter Ct Hematology and Oncology

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Stamford Hospital

    Stamford, Connecticut 06904
    United States

    Site Not Available

  • Southeast Florida Hematology-Oncology Group, PA

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • CSNF - Central Business Office

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Jupiter Medical Center

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34203
    United States

    Site Not Available

  • University Cancer & Blood Center, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Candler Hospital

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois 60612
    United States

    Site Not Available

  • PMG Research of DuPage Medical Group

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Presence Cancer Care / JOHA

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Illinois CancerCare, P.C.

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Orchard Healthcare Reasearch Inc

    Skokie, Illinois 60077
    United States

    Site Not Available

  • SIU School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • PMG Research of McFarland Clinic

    Ames, Iowa 50010
    United States

    Site Not Available

  • Des Moines Oncology Research Associate

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Baptist Health-Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Baptist Health

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Norton Cancer Institute-Pavilion

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Baptist Health- Paducah

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Greater Baltimore Medical Center

    Baltimore, Maryland 68506
    United States

    Site Not Available

  • Holy Cross Hospital Resource Center Department of Cancer Research

    Silver Spring, Maryland 20902
    United States

    Site Not Available

  • Beverly Hospital, Oncology

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Lowell General Hospital

    Lowell, Massachusetts 01854
    United States

    Site Not Available

  • Cancer Research Consortium of West Michigan (CRCWM)

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Cancer and Hematology Centers of Western Michigan, PC

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Ascension Providence Hospitals

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Metro-Minnesota Community Oncology Research Consortium (MMCORC)

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Park Nicollet Institute - Oncology Research

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • St. Dominic's Gynecologic Oncology

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • North Mississippi Medical Center Hematology and Oncology

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Mercy Cancer Center

    Joplin, Missouri 64804
    United States

    Site Not Available

  • Mercy Hospital

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Missouri Baptist Medical Center

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Mercy Cancer and Hematology Clinic

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Nebraska Hematology-Oncology -- Lincoln

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Somnos Laboratories, Inc.

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Cancer Care Specialists

    Reno, Nevada 89519
    United States

    Site Not Available

  • The Minniti Center for Hematology and Oncology

    Mickleton, New Jersey 08056
    United States

    Site Not Available

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • Brooklyn Urology Research Group

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Richmond University Medical Center

    Staten Island, New York 10310
    United States

    Site Not Available

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Associated Medical Professionals

    Syracuse, New York 13210
    United States

    Site Not Available

  • Cone Health Cancer Center

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • PMG Research of Hickory, LLC

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • PMG Research of Rocky Mount

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • PMG Research of Piedmont

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Marion L. Shepard Cancer Center

    Washington, North Carolina 27889
    United States

    Site Not Available

  • Zimmer Cancer Center

    Wilmington, North Carolina 28402
    United States

    Site Not Available

  • Hematology & Oncology Associates, Inc.

    Canton, Ohio 44708
    United States

    Site Not Available

  • Tri-County Hematology & Oncology Associates, Inc.

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma 73505
    United States

    Site Not Available

  • Genie Jackson Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Mercy Oncology Research

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Women & Infants Hospital

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Charleston Cancer Center

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • McLeod Center for Cancer Treatment and Research

    Florence, South Carolina 29506
    United States

    Site Not Available

  • Saint Francis Cancer Center Research Department

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Lowcountry Urology/PMG Research of Charleston, LLC

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Spartanburg Medical Center: Gibbs Cancer Center & Research Institute

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Lexington Medical Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • RH Clinical Research

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • PMG Research of Bristol, LLC

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • Christus Spohn Cancer Center

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • University of Texas Health Science Center

    Houston, Texas 77030
    United States

    Site Not Available

  • San Antonio Military Medical Center

    San Antonio, Texas 78234
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Cancer Treatment Center

    Texarkana, Texas 75503
    United States

    Site Not Available

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Community Cancer Trials of Utah

    Ogden, Utah 84405
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Virginia Cancer Institute

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

  • Seattle Urology Research Center

    Burien, Washington 98166
    United States

    Site Not Available

  • MultiCare Regional Cancer Center

    Tacoma, Washington 98405
    United States

    Site Not Available

  • CAMC Clinical Trials Center

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Mon Health Medical Center

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • West Virginia University Cancer Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • HSHS St. Vincent Hospital

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • Michael Berry Building-Oncology

    Janesville, Wisconsin 53548
    United States

    Site Not Available

  • UW Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • ProHealth Care Research Institute

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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