Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
- Conditions
- Stomach CancerBreast CancerLung CancerColorectal CancerBladder CancerUterine CancerRenal Pelvis CancerOvarian CancerProstate CancerKidney Cancer
- Registration Number
- NCT03662204
- Lead Sponsor
- Exact Sciences Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5133
-
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.
-
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.
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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.
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Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
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Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomarker Evaluation Point in time (one day) blood collection at enrollment Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (119)
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
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
Scroll for more (109 remaining)Mayo Clinic Hospital🇺🇸Phoenix, Arizona, United States