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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03517332.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationQuantgene Inc.
