Clinical trial NCT04264767: Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
Official title: Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Solid Tumor
Hematologic Neoplasms
Keywords: Cancer
Methylation
cfDNA
Solid Tumor
Hematologic Neoplasms
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 800
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 72 Months
measure: 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
timeFrame: 72 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group - Wilson Terrace
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices
state: California
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Nucleix Ltd.
name: Shmulik Adler
role: STUDY_DIRECTOR
References: