Clinical trial NCT05693012: Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
Official title: Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: multiple myeloma
early detection
liquid biopsy
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2023-01-20
Enrollment: 398
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.
timeFrame: 12 months
Secondary outcomes:
measure: The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.
timeFrame: 12 months
measure: The performance of a cfDNA methylation-based prognostic model for multiple myeloma.
timeFrame: 12 months
measure: The specific cfDNA methylation landscape of multiple myeloma in China
timeFrame: 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences & Peking Union Medical College
name: Lugui Qiu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: