Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis

NCT05686447 | Recruiting

• 1 other identifier: Zhujianghjd
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.

Conditions

Monoclonal Gammopathies; Multiple Myeloma; M-protein

Keywords

M-protein

Outcome Measures

Primary Outcomes (1)

• M-protein

  M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry

  baseline

Study Arms (2)

Multiple myeloma

Multiple myeloma (MM) is a hematologic malignant tumor characterized by abnormally cloned plasma cells in bone marrow, whose growth can lead to destructive bone injury, acute kidney injury, anemia, and hypercalcemia.

Other: Observational studies, no intervention

Healthy control

Individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex.

Other: Observational studies, no intervention

Interventions

Observational studies, no intervention OTHER

Observational studies, no intervention

Healthy control; Multiple myeloma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with Multiple myeloma hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled

Sponsors & Collaborators

• Zhujiang Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Paraproteinemias; Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongwei Zhou, Professor

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Hongwei Zhou, Professor

CONTACT

18688489622; hzhou@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)