Dayton, Ohio 45429

  • Other Cancer


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 summary:

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.


Inclusion Criteria: - This study will include subjects that are diagnosed with a malignancy (cohort 1) 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



Primary Contact:

Monika Hagen, M.D.

Backup Contact:


Location Contact:

Dayton, Ohio 45429
United States

Molly Regan

Site Status: Recruiting

Data Source:

Date Processed: February 03, 2023

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.