Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT05693012
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 398}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.', 'timeFrame': '12 months'}, {'measure': 'The performance of a cfDNA methylation-based prognostic model for multiple myeloma.', 'timeFrame': '12 months', 'description': 'Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma.'}, {'measure': 'The specific cfDNA methylation landscape of multiple myeloma in China', 'timeFrame': '12 months', 'description': 'The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'early detection', 'liquid biopsy'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants will be recruited from the participating medical center and assigned into three arms, including participants with newly diagnosed multiple myeloma, benign hematologic disorders and healthy participants.', 'eligibilityCriteria': 'Inclusion Criteria for Cancer Participants:\n\n* Age 40-75 years\n* Ability to provide a written informed consent\n* Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma\n* No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw\n\nInclusion Criteria for Benign Disease Participants:\n\n* Age 40-75 years\n* Ability to provide a written informed consent\n* Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders\n* No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw\n\nInclusion Criteria for Healthy Participants\n\n* Age 40-75 years\n* Ability to provide a written informed consent\n* No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw\n\nExclusion Criteria for All Participants:\n\n* Insufficient qualified blood samples\n* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant\n* Recipient of blood transfusion within 7 days prior to blood draw\n* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)\n\nAdditional Exclusion Criteria for Cancer Participants:\n\n• Other current malignant diseases or multiple primary tumors\n\nAdditional Exclusion Criteria for Benign Disease Participants:\n\n• Current or history of malignancies\n\nAdditional Exclusion Criteria for Healthy Participants:\n\n* Recipient of anti-infectious therapy within 14 days prior to study blood draw\n* Prior or ongoing treatment of cancer within 3 years prior to study blood draw\n* Current autoimmune disease or clinically significant or uncontrolled comorbidities'}, 'identificationModule': {'nctId': 'NCT05693012', 'briefTitle': 'Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study', 'orgStudyIdInfo': {'id': 'RSCD2022004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Arm', 'description': 'participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.', 'interventionNames': ['Diagnostic Test: cfDNA methylation assessment']}, {'label': 'Benign Arm', 'description': 'Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.', 'interventionNames': ['Diagnostic Test: cfDNA methylation assessment']}, {'label': 'Healthy arm', 'description': 'Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.', 'interventionNames': ['Diagnostic Test: cfDNA methylation assessment']}], 'interventions': [{'name': 'cfDNA methylation assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment', 'armGroupLabels': ['Benign Arm', 'Cancer Arm', 'Healthy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lugui Qiu, MD, Ph.D', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '23909172'}], 'facility': 'National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Lugui Qiu, MD, Ph.D', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '23909172'}, {'name': 'Mu Hao, Ph.D', 'role': 'CONTACT', 'email': 'haomu@ihcams.ac.cn'}], 'overallOfficials': [{'name': 'Lugui Qiu, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences & Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qiu Lugui', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Burning Rock Dx Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of lymphoma & myeloma center', 'investigatorFullName': 'Qiu Lugui', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}