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Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA | Clinical Trials | Clareo Health

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Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

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

NCT04264767•Nucleix Ltd.

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

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age ≥ 22 years
•2. Subjects who are willing and able to provide written informed consent.
•3. Subjects with confirmed diagnosis of cancer (primary or recurrent) at all stages, however did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies). Recent cancer staging should be within 60 days prior to baseline visit.
•1. Age 45 to 80 years
•2. Subjects who are willing and able to provide written informed consent

Exclusion Criteria

•1. Known prior diagnosis of cancer except of:
•1. Fully resected non-melanoma skin cancer
•2. History of the original cancer in cases of recurrent disease.
•2. Current co-diagnosis of another type of cancer.
•3. Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy
•4. Pregnancy (by self-report)
•5. Current febrile illness
•6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
•7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
•1. Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer
+7 more criteria

Locations (3)

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

Sourasky Medical Center

Tel Aviv, Israel

Key Dates

Start Date

April 17, 2019

Primary Completion Date

January 30, 2021

Completion Date

January 30, 2021

Last Updated

June 8, 2022

Enrollment

800

ACTUAL participants

Conditions

CancerSolid TumorHematologic Neoplasms

Interventions

Blood collection

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

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