CancerNCT04264767
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
An observational study of Cancer and Solid Tumor, run by Nucleix Ltd. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Neoplasms
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Apr 2019to 30 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age 45 to 80 years
- Subjects who are willing and able to provide written informed consent
Who cannot join
- 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)
Show all 17Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Los Angeles Hematology Oncology Medical Group - Wilson Terrace
Glendale, California, 91206
Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices
Los Angeles, California, 90017
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer, Solid Tumor, Hematologic Neoplasms
- Being tested
- Blood collection
- Keywords
- Cancer, Methylation, cfDNA, Solid Tumor, Hematologic Neoplasms
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Peripheral blood collection via routine venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Cases Group | Peripheral blood collection via routine venipuncture Receives: Procedure: Blood collection | |
| Control Group | Peripheral blood collection via routine venipuncture Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start17 Apr 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shmulik Adler, Study director, Nucleix Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264767
- Sponsor's protocol ID
- PNC-RND-UR-001
- Status last verified
- Jun 2022
- First submitted
- 9 Feb 2020
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. The analysis will be performed by the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT04264767
- Acronym / sponsor ID
- PNC-RND-UR-001
- Conditions
- Cancer, Solid Tumor, Hematologic Neoplasms
- Keywords
- Cancer, Methylation, cfDNA, Solid Tumor, Hematologic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases Group | – | Procedure: Blood collectionPeripheral blood collection via routine venipuncture |
| Control Group | – | Procedure: Blood collectionPeripheral blood collection via routine venipuncture |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Age 45 to 80 years
- Subjects who are willing and able to provide written informed consent
Key exclusion criteria (17 listed)
- Known prior diagnosis of cancer except of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionPeripheral blood collection via routine venipuncture | Procedure or surgery | Cases Group, Control Group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No. No IPD will be shared. The analysis will be performed by the sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmulik Adler study director
Nucleix Ltd.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by Nucleix Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 72 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.