Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
NCT ID: NCT04264767
Last Updated: 2022-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2019-04-17
2021-01-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases Group
Peripheral blood collection via routine venipuncture
Blood collection
Peripheral blood collection via routine venipuncture
Control Group
Peripheral blood collection via routine venipuncture
Blood collection
Peripheral blood collection via routine venipuncture
Interventions
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Blood collection
Peripheral blood collection via routine venipuncture
Eligibility Criteria
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Inclusion Criteria
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.
1. Age 45 to 80 years
2. Subjects who are willing and able to provide written informed consent
Exclusion Criteria
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
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
22 Years
80 Years
ALL
Yes
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shmulik Adler
Role: STUDY_DIRECTOR
Nucleix Ltd.
Locations
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Los Angeles Hematology Oncology Medical Group - Wilson Terrace
Glendale, California, United States
Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices
Los Angeles, California, United States
Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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PNC-RND-UR-001
Identifier Type: -
Identifier Source: org_study_id
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