Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma

Qiu Lugui

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Diagnostic Test: cfDNA methylation assessment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05693012

RSCD2022004

Details and patient eligibility

About

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.

Enrollment: 398 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

398 participants in 3 patient groups

Cancer Arm

Description:

participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.

Treatment:

Diagnostic Test: cfDNA methylation assessment

Benign Arm

Description:

Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.

Treatment:

Diagnostic Test: cfDNA methylation assessment

Healthy arm

Description:

Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

Treatment:

Diagnostic Test: cfDNA methylation assessment