Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Pelvis Cancer, Stomach Cancer, Uterine Cancer
Conditions
Keywords
blood draw, sample collection
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.
Interventions
OTHERBlood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
Sponsors
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed