Clinical trial NCT03662204: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Official title: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: blood draw
sample collection
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 5133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker Evaluation
timeFrame: Point in time (one day) blood collection at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging Research
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, PC
state: Arizona
city: Fort Smith
country: United States
facility: Mercy Research-Fort Smith
state: Arkansas
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Fowler Family Center for Cancer Care
state: Arkansas
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Concord
country: United States
facility: John Muir Clinical Research
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Newport Beach
country: United States
facility: Office of John Homan, MD
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Orange
country: United States
facility: UCI Department of Urology
state: California
city: Saint Helena
country: United States
facility: Adventist Health - Saint Helena Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Aurora
country: United States
facility: RMR VA Medical Center
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Norwich
country: United States
facility: Easter Ct Hematology and Oncology
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Southeast Florida Hematology-Oncology Group, PA
state: Florida
city: Jacksonville
country: United States
facility: CSNF - Central Business Office
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Savannah
country: United States
facility: Candler Hospital
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Downers Grove
country: United States
facility: PMG Research of DuPage Medical Group
state: Illinois
city: Joliet
country: United States
facility: Presence Cancer Care / JOHA
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Reasearch Inc
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Ames
country: United States
facility: PMG Research of McFarland Clinic
state: Iowa
city: Des Moines
country: United States
facility: Des Moines Oncology Research Associate
state: Iowa
city: Edgewood
country: United States
facility: Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health-Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute-Pavilion
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Paducah
country: United States
facility: Baptist Health- Paducah
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital Resource Center Department of Cancer Research
state: Maryland
city: Beverly
country: United States
facility: Beverly Hospital, Oncology
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan, PC
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan (CRCWM)
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospitals
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Oncology Research Consortium (MMCORC)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute - Oncology Research
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic's Gynecologic Oncology
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center Hematology and Oncology
state: Mississippi
city: Joplin
country: United States
facility: Mercy Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Cancer and Hematology Clinic
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology -- Lincoln
state: Nebraska
city: Lincoln
country: United States
facility: Somnos Laboratories, Inc.
state: Nebraska
city: Reno
country: United States
facility: Cancer Care Specialists
state: Nevada
city: Mickleton
country: United States
facility: The Minniti Center for Hematology and Oncology
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount
state: North Carolina
city: Statesville
country: United States
facility: PMG Research of Piedmont
state: North Carolina
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Wilmington
country: United States
facility: Zimmer Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Hematology & Oncology Associates, Inc.
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates, Inc.
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Genie Jackson Stephenson Cancer Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Oncology Research
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Florence
country: United States
facility: McLeod Center for Cancer Treatment and Research
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Cancer Center Research Department
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Urology/PMG Research of Charleston, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: RH Clinical Research
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Corpus Christi
country: United States
facility: Christus Spohn Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Texarkana
country: United States
facility: Cancer Treatment Center
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Morgantown
country: United States
facility: Mon Health Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Cancer Institute
state: West Virginia
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital
state: Wisconsin
city: Janesville
country: United States
facility: Michael Berry Building-Oncology
state: Wisconsin
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth Care Research Institute
state: Wisconsin
Study officials:
References: