Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Hematologic Neoplasms; Solid Tumor
• Intervention / Treatment: Procedure: Blood collection

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 Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Sourasky Medical Center
• United States
  • California
    • Glendale, California, United States, 91206
      • Los Angeles Hematology Oncology Medical Group - Wilson Terrace
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cases group will include subjects of at least 22 years old that were already diagnosed with cancer but did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancer (i.e. treatment naïve subjects). Enrollment for this group will be stratified to enable representation of subjects with multiple tumor histological types, stage and grade.

The control group will include healthy subjects, 45-80 years old. The subjects in the control group should be without any previous or current diagnosis of cancer except completely resected non-melanoma skin cancer.

Description

Inclusion Criteria - Cases:

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.

Exclusion Criteria - Cases:

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

Inclusion Criteria - Controls:

1. Age 45 to 80 years
2. Subjects who are willing and able to provide written informed consent

Exclusion Criteria - Controls:

1. Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer
2. Currently in work-up due to suspicion of cancer of any kind
3. Oral or IV corticosteroid use in past 14 days prior to blood draw
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
8. Life expectancy < 24 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases Group; Peripheral blood collection via routine venipuncture	Procedure: Blood collection; Peripheral blood collection via routine venipuncture
Control Group; Peripheral blood collection via routine venipuncture	Procedure: Blood collection; Peripheral blood collection via routine venipuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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	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

Collaborators and Investigators

• Sponsor: Nucleix Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Solid Tumor; Hematologic Neoplasms; cfDNA; Methylation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: PNC-RND-UR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared. The analysis will be performed by the sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No