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

Exact Sciences Corporation119 sites in 1 country5,133 target enrollmentAugust 23, 2018

ConditionsBreast 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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Exact Sciences Corporation
Enrollment: 5133
Locations: 119
Primary Endpoint: Biomarker Evaluation
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 23, 2018

End Date

March 31, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Exact Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Biomarker Evaluation

Time Frame: 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.