The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    UR001
Previous Study | Return to List | Next Study

Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264767
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Nucleix Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Cancer Solid Tumor Hematologic Neoplasms 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study
Actual Study Start Date : April 17, 2019
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : January 30, 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 [ Time Frame: 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

  2. 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 [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Plasma samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264767


Locations
Layout table for location information
United States, California
Los Angeles Hematology Oncology Medical Group - Wilson Terrace
Glendale, California, United States, 91206
Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices
Los Angeles, California, United States, 90017
Israel
Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Nucleix Ltd.
Investigators
Layout table for investigator information
Study Director: Shmulik Adler Nucleix Ltd.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nucleix Ltd.
ClinicalTrials.gov Identifier: NCT04264767    
Other Study ID Numbers: PNC-RND-UR-001
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared. The analysis will be performed by the sponsor

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nucleix Ltd.:
Cancer
Methylation
cfDNA
Solid Tumor
Hematologic Neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases