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Trial Title:
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
NCT ID:
NCT05693012
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
multiple myeloma
early detection
liquid biopsy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cfDNA methylation assessment
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
Arm group label:
Benign Arm
Arm group label:
Cancer Arm
Arm group label:
Healthy arm
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
- 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
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu, MD, Ph.D
Phone:
23909172
Email:
qiulg@ihcams.ac.cn
Start date:
August 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Qiu Lugui
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Dx Co., Ltd.
Agency class:
Industry
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05693012
