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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03662204
Other study ID # 2018-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2018
Est. completion date December 1, 2020

Study information

Verified date May 2019
Source Exact Sciences Corporation
Contact Alexandra Massoud
Phone 608-957-5652
Email amassoud@exactsciences.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3750
Est. completion date December 1, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin 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 Design


Related Conditions & MeSH terms

  • Bladder Cancer
  • Breast Cancer
  • Carcinoma, Renal Cell
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Kidney Cancer
  • Kidney Neoplasms
  • Liver Cancer
  • Liver Neoplasms
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pelvic Neoplasms
  • Prostate Cancer
  • Renal Pelvis Cancer
  • Stomach Cancer
  • Stomach Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cancer
  • Uterine Neoplasms

Intervention

Other:
Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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