Clinical Trial - NCT03662204

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

Recruiting

Sponsor: Exact Sciences Corporation

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03662204

Protocol Info

Short Description: Blood Sample Collection In Untreated Solid Tumors
Long Description: Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Solid Tumors
MGH Status: Open
Sponsor: Exact Sciences Corporation
Disease Program: Breast

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Bladder Cancer Uterine Cancer Kidney Cancer Renal Pelvis Cancer Pancreatic Cancer Liver Cancer Stomach Cancer Ovarian Cancer Esophageal Cancer Blood Sample Collection
Study Type Observational
Official Title Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Primary Outcome Measures

Biomarker Evaluation [Time Frame: Point in time (one day) blood collection at enrollment] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 7500
Study Start Date: August 2018
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: July 2021
Arms Assigned Interventions

: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.
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.

: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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03662204

Locations

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

Sponsors and Collaborators

Exact Sciences Corporation

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03662204
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Exact Sciences Corporation:

blood draw

sample collection

Additional relevant MeSH terms:

Kidney Neoplasms

Stomach Neoplasms

Uterine Neoplasms

Pelvic Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on September 03, 2020