Multiple Myeloma
Conditions
Keywords
multiple myeloma, early detection, liquid biopsy
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.
Interventions
DIAGNOSTIC_TESTcfDNA 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
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Qiu Lugui
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactLugui Qiu, MD, Ph.D
Backup ContactMu Hao, Ph.D
Outcome results
None listed