Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Arm participants with newly diagnosed multiple myeloma, from whom blood samples will be collected. |
Diagnostic Test: 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. |
Diagnostic Test: 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. |
Diagnostic Test: 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
|
Outcome Measures
Primary Outcome Measures
- The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma. [12 months]
Secondary Outcome Measures
- The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages. [12 months]
- The performance of a cfDNA methylation-based prognostic model for multiple myeloma. [12 months]
Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma.
- The specific cfDNA methylation landscape of multiple myeloma in China [12 months]
The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.
Eligibility Criteria
Criteria
Inclusion Criteria for Cancer Participants:
-
Age 40-75 years
-
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
Inclusion Criteria for Benign Disease Participants:
-
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
Inclusion Criteria for Healthy Participants
-
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 for All Participants:
-
Insufficient qualified blood samples
-
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
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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)
Additional Exclusion Criteria for Cancer Participants:
• Other current malignant diseases or multiple primary tumors
Additional Exclusion Criteria for Benign Disease Participants:
• Current or history of malignancies
Additional Exclusion Criteria for Healthy Participants:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin | China | 300020 |
Sponsors and Collaborators
- Qiu Lugui
- Guangzhou Burning Rock Dx Co., Ltd.
Investigators
- Principal Investigator: Lugui Qiu, MD, Ph.D, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RSCD2022004