Centerville, Ohio 45459

  • Other Cancer

Purpose:

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.


Criteria:

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


NCT ID:

NCT03517332


Primary Contact:

Monika Hagen, M.D.
Email: mh@quantgene.com


Backup Contact:

N/A


Location Contact:

Centerville, Ohio 45459
United States

James Ouellette, D.O.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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