NCT03517332

Circulating Tumor DNA Exposure in Peripheral Blood

Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Quantgene Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer
• Pancreatic Adenocarcinoma
• Gastric Cancer
• Hepatocellular Carcinoma
• Non-small Cell Lung Cancer
• Bladder Cancer
• Melanoma
• Ovarian Cancer
• Adrenocortical Cancer
• Breast Cancer
• Other Cancer

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-05-07
• Last updated: 2018-11-20

Locations

6 sites across 2 countries: United States, Switzerland