NCT04264767

Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Nucleix Ltd. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Nucleix EpiCheck® tests analyzes the methylation pattern in a panel of DNA methylation biomarkers and determines whether this pattern is consistent with cancer under test or with non-cancer tissue. This study is being performed as part of the development process of the Pan Cancer EpiCheck test which includes the identification of different methylation profiles in various cancer types and healthy controls.

Detailed description

The aim of this study is to characterize methylation patterns that will distinguish cancer from normal samples and will be able to recognize the origin of the cancer by collecting cfDNA (circulating free DNA) from blood samples collected from patients with a new diagnosis of cancer and from healthy volunteers who do not have diagnosis or history of cancer. Identifying those methylation patterns may assist in the development of blood test that will be able to detect the presence and the origin of wide range of human cancers

Conditions

• Cancer
• Solid Tumor
• Hematologic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Blood collection	Peripheral blood collection via routine venipuncture

Timeline

• Start date: 2019-04-17
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2020-02-11
• Last updated: 2022-06-08

Locations

3 sites across 2 countries: United States, Israel