Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
NCT ID: NCT05693012
Last Updated: 2023-01-20
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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UNKNOWN
398 participants
OBSERVATIONAL
2022-08-01
2024-12-31
Brief Summary
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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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Cancer Arm
participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.
cfDNA methylation assessment
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
Benign Arm
Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.
cfDNA methylation assessment
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
Healthy arm
Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.
cfDNA methylation assessment
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
Interventions
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cfDNA methylation assessment
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
Eligibility Criteria
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Inclusion Criteria
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
* No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw
* Age 40-75 years
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders
* No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw
* Age 40-75 years
* Ability to provide a written informed consent
* No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw
Exclusion Criteria
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
* Recipient of blood transfusion within 7 days prior to blood draw
* 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)
• Other current malignant diseases or multiple primary tumors
• Current or history of malignancies
* Recipient of anti-infectious therapy within 14 days prior to study blood draw
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Current autoimmune disease or clinically significant or uncontrolled comorbidities
40 Years
75 Years
ALL
No
Sponsors
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Guangzhou Burning Rock Dx Co., Ltd.
INDUSTRY
Qiu Lugui
OTHER
Responsible Party
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Qiu Lugui
Director of lymphoma & myeloma center
Principal Investigators
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Lugui Qiu, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences & Peking Union Medical College
Locations
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National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RSCD2022004
Identifier Type: -
Identifier Source: org_study_id
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