Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

  • STATUS
    Recruiting
  • End date
    Dec 28, 2026
  • participants needed
    6000
  • sponsor
    Nucleix Ltd.
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Updated on 16 February 2024
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cancer
cfdna

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.

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

Details
Condition Hematologic Malignancy, Blood disorder, Cancer, Solid Tumor
Age 22years - 80years
Treatment Blood collection
Clinical Study IdentifierNCT04264767
SponsorNucleix Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer
Currently in work-up due to suspicion of cancer of any kind
Oral or IV corticosteroid use in past 14 days prior to blood draw
Pregnancy (by self-report)
Current febrile illness
Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
Life expectancy < 24 months
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