Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

Completed

• Conditions: Cancer; Hematologic Neoplasms; Solid Tumor
• Interventions: Procedure: Blood collection

• Registration Number: NCT04264767
• Lead Sponsor: Nucleix Ltd.

Brief 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

Study Timeline

• Study Start: 2019-04-17
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Study First Posted: 2020-02-11
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases Group	Blood collection	Peripheral blood collection via routine venipuncture
Control Group	Blood collection	Peripheral blood collection via routine venipuncture

Primary Outcome Measures

Name	Time	Method
To collect blood and urine samples and clinical data in order to characterize methylation patterns that will discriminate cancer and normal (non-cancer) samples and the origin of cancer	72 Months	To collect blood and urine samples and clinical data in order to characterize methylation patterns that will discriminate cancer and normal (non-cancer) samples and the origin of cancer
To develop a molecular blood test that will be able to detect wide range of human cancers based on change in methylation patterns between cancer and normal samples	72 Months	To develop a molecular blood test that will be able to detect wide range of human cancers based on change in methylation patterns between cancer and normal samples

Trial Locations

Locations (3)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Los Angeles Hematology Oncology Medical Group - Wilson Terrace; 🇺🇸 Glendale, California, United States

Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices; 🇺🇸 Los Angeles, California, United States