Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Quantgene Inc.
- Enrollment
- 10000
- Locations
- 6
- Primary Endpoint
- Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
Detailed Description
This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.
Investigators
Eligibility Criteria
Inclusion Criteria
- •This study will include subjects that are diagnosed with a malignancy (cohort
- •and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).
- •Subjects of both cohorts must:
- •Be of age ≥ 18
- •Provide written consent for study participation
- •Subject of cohort 1 must:
- •Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma
- •Subjects of cohort 2 must:
- •Meet the listed matching criteria
Exclusion Criteria
- •Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy
- •Subjects of cohort 2 must not:
- •Have been diagnosed/treated for a malignancy previously
Outcomes
Primary Outcomes
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
Time Frame: 28 Months
The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).