- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693012
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lugui Qiu, MD, Ph.D
- Phone Number: 23909172
- Email: qiulg@ihcams.ac.cn
Study Contact Backup
- Name: Mu Hao, Ph.D
- Email: haomu@ihcams.ac.cn
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300020
- Recruiting
- National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
-
Contact:
- Lugui Qiu, MD, Ph.D
- Phone Number: 23909172
- Email: qiulg@ihcams.ac.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy arm
Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.
|
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
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Cancer Arm
participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.
|
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.
|
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.
Time Frame: 12 months
|
12 months
|
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The performance of a cfDNA methylation-based prognostic model for multiple myeloma.
Time Frame: 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.
|
12 months
|
The specific cfDNA methylation landscape of multiple myeloma in China
Time Frame: 12 months
|
The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lugui Qiu, MD, Ph.D, Chinese Academy of Medical Sciences & Peking Union Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- RSCD2022004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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