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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03662204
Other study ID # 2018-01
Secondary ID
Status Recruiting
First received
Last updated
Start date August 23, 2018
Est. completion date November 1, 2019

Study information

Verified date February 2019
Source Exact Sciences Corporation
Contact Alexandra Massoud
Phone 608-957-5652
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.


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 November 1, 2019
Est. primary completion date September 6, 2019
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.


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


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


Country Name City State
United States Albany Medical College Albany New York
United States PMG Research of McFarland Clinic Ames Iowa
United States Piedmont Cancer Institute, PC Atlanta Georgia
United States Greater Baltimore Medical Center Baltimore Maryland
United States St. Luke's University Health Network Bethlehem Pennsylvania
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 CAMC Clinical Trials Center Charleston West Virginia
United States Charleston Cancer Center Charleston South Carolina
United States John Muir Clinical Research Concord California
United States The Urology Center of Colorado Denver Colorado
United States PMG Research of DuPage Medical Group Downers Grove Illinois
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 Marin Cancer Care Greenbrae California
United States PMG Research of Hickory, LLC Hickory North Carolina
United States CSNF - Central Business Office Jacksonville Florida
United States Presence Cancer Care / JOHA Joliet Illinois
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 Middlesex Hospital Middletown Connecticut
United States Mon Health Medical Center Morgantown West Virginia
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 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 PMG Research of Rocky Mount Rocky Mount North Carolina
United States Adventist Health - Saint Helena Hospital Saint Helena California
United States Park Nicollet Institute - Oncology Research Saint Louis Park Minnesota
United States Sun Research Institute San Antonio Texas
United States Holy Cross Hospital Resource Center Department of Cancer Research Silver Spring Maryland
United States Orchard Healthcare Reasearch Inc Skokie Illinois
United States Stamford Hospital Stamford Connecticut
United States PMG Research of Piedmont Statesville North Carolina
United States Associated Medical Professionals Syracuse New York
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 Urology of Virginia, PLLC Virginia Beach Virginia
United States Marion L. Shepard Cancer Center Washington North Carolina
United States Innovative Clinical Research Institute Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 


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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