Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

NCT04264767 | Completed

• 1 other identifier: PNC-RND-UR-001
• Study Type: observational
• Target: 800
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cancer; Solid Tumor; Hematologic Neoplasms

Keywords

Cancer; Methylation; cfDNA; Solid Tumor; Hematologic Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cases Group

Peripheral blood collection via routine venipuncture

Procedure: Blood collection

Control Group

Peripheral blood collection via routine venipuncture

Procedure: Blood collection

Interventions

Blood collection PROCEDURE

Peripheral blood collection via routine venipuncture

Cases Group; Control Group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 22 years
• Subjects who are willing and able to provide written informed consent.
• 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.

You may not qualify if:

• Known prior diagnosis of cancer except of:
• Fully resected non-melanoma skin cancer
• History of the original cancer in cases of recurrent disease.
• Current co-diagnosis of another type of cancer.
• 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
• 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
• Age 45 to 80 years
• Subjects who are willing and able to provide written informed consent
• 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)

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (3)

Los Angeles Hematology Oncology Medical Group - Wilson Terrace

Glendale, California, 91206, United States

Location

Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices

Los Angeles, California, 90017, United States

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shmulik Adler

  Nucleix Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: April 17, 2019
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)