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

NCT05693012 | Unknown DMC

• 1 other identifier: RSCD2022004
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; early detection; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.

  12 months

Secondary Outcomes (3)

• 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

• The specific cfDNA methylation landscape of multiple myeloma in China

  12 months

Study Arms (3)

Cancer Arm

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

Diagnostic Test: cfDNA methylation assessment

Benign Arm

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

Diagnostic Test: cfDNA methylation assessment

Healthy arm

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

Diagnostic Test: cfDNA methylation assessment

Interventions

cfDNA methylation assessment DIAGNOSTIC_TEST

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; Cancer Arm; Healthy arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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
• Age 40-75 years
• Ability to provide a written informed consent
• No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw

You may not qualify if:

• 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)
• Other current malignant diseases or multiple primary tumors
• Current or history of malignancies
• 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

Sponsors & Collaborators

• Qiu Lugui: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Lugui Qiu, MD, Ph.D

  Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lugui Qiu, MD, Ph.D

CONTACT

23909172; qiulg@ihcams.ac.cn

Mu Hao, Ph.D

CONTACT

haomu@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of lymphoma & myeloma center

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 20, 2023
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

CN (1)