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

Completed

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03662204

Run by

Exact Sciences Corporation

People needed

5133

Starts

2018-08-23

Expected to finish

2022-03-31

Last updated by the study team

2022-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male or female > 18 years of age.
• 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.
• 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.

You may not qualify if…

• Prior or concurrent cancer diagnosis defined as:
• Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
• Recurrence of the same primary cancer within any timeframe; OR
• Concurrent diagnosis of multiple primary cancers
• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
• 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.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
• IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
• 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.

Where it is running

• Scottsdale Medical Imaging Research — Scottsdale, Arizona, United States
• Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Urological Associates of Southern Arizona, PC — Tucson, Arizona, United States
• Mercy Research-Fort Smith — Fort Smith, Arkansas, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• NEA Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• CARTI Cancer Center — Little Rock, Arkansas, United States
• John Muir Clinical Research — Concord, California, United States
• Marin Cancer Care — Greenbrae, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Office of John Homan, MD — Newport Beach, California, United States
• North County Oncology — Oceanside, California, United States
• UCI Department of Urology — Orange, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Adventist Health - Saint Helena Hospital — St. Helena, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• RMR VA Medical Center — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• Easter Ct Hematology and Oncology — Norwich, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Southeast Florida Hematology-Oncology Group, PA — Fort Lauderdale, Florida, United States
• CSNF - Central Business Office — Jacksonville, Florida, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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