Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-03 @ 10:42 AM
Study NCT ID:
NCT04264767
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2020-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-02-09', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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'}, {'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', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Methylation', 'cfDNA', 'Solid Tumor', 'Hematologic Neoplasms'], 'conditions': ['Cancer', 'Solid Tumor', 'Hematologic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Cases:\n\n1. Age ≥ 22 years\n2. Subjects who are willing and able to provide written informed consent.\n3. 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.\n\nExclusion Criteria - Cases:\n\n1. Known prior diagnosis of cancer except of:\n\n 1. Fully resected non-melanoma skin cancer\n 2. History of the original cancer in cases of recurrent disease.\n2. Current co-diagnosis of another type of cancer.\n3. 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\n4. Pregnancy (by self-report)\n5. Current febrile illness\n6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.\n7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant\n\nInclusion Criteria - Controls:\n\n1. Age 45 to 80 years\n2. Subjects who are willing and able to provide written informed consent\n\nExclusion Criteria - Controls:\n\n1. Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer\n2. Currently in work-up due to suspicion of cancer of any kind\n3. Oral or IV corticosteroid use in past 14 days prior to blood draw\n4. Pregnancy (by self-report)\n5. Current febrile illness\n6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.\n7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant\n8. Life expectancy \\< 24 months'}, 'identificationModule': {'nctId': 'NCT04264767', 'briefTitle': 'Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nucleix Ltd.'}, 'officialTitle': 'Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study', 'orgStudyIdInfo': {'id': 'PNC-RND-UR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases Group', 'description': 'Peripheral blood collection via routine venipuncture', 'interventionNames': ['Procedure: Blood collection']}, {'label': 'Control Group', 'description': 'Peripheral blood collection via routine venipuncture', 'interventionNames': ['Procedure: Blood collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'PROCEDURE', 'description': 'Peripheral blood collection via routine venipuncture', 'armGroupLabels': ['Cases Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Hematology Oncology Medical Group - Wilson Terrace', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Hematology Oncology Medical Group - Good Samaritan Medical Offices', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Shmulik Adler', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nucleix Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared. The analysis will be performed by the sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nucleix Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}