NCT05965115

Brief Summary

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple myeloma. We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
109mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jul 2023Aug 2035

First Submitted

Initial submission to the registry

June 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2035

Expected
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

June 30, 2023

Last Update Submit

July 31, 2023

Conditions

Multiple MyelomaMonoclonal Gammopathy of Undetermined Significance

Keywords

Monoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaEarly Tumor Screening

Outcome Measures

Primary Outcomes (2)

  • The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives

    The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening

    2 Years

  • Time to progression (TTP) from MGUS to overt multiple myeloma

    The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date.

    10 Years

Secondary Outcomes (2)

  • Overall survival of MGUS patients

    10 Years

  • Quality of life (QoL) of MGUS patients

    10 Years

Interventions

Sample of BloodDIAGNOSTIC_TEST

All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The first-degree relatives of patients with multiple myeloma in the Chinese population.

You may qualify if:

  • Male or female over the age of 18;
  • First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
  • Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
  • Participants should be willing and able to follow the study follow-up plan and other protocol requirements.

You may not qualify if:

  • Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Li J, Wang Y, Liu P. The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. J Cancer. 2019 Aug 27;10(20):4807-4813. doi: 10.7150/jca.32103. eCollection 2019.

    PMID: 31598151RESULT

MeSH Terms

Conditions

Multiple MyelomaMonoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesHypergammaglobulinemia

Study Officials

  • Peng Liu, PhD, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Liu, PhD, MD

CONTACT

+8621-64041990liu.peng@zs-hospital.sh.cn

Jing Li, MD

CONTACT

+8621-64041990li.jing6@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Hematology

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 28, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2035

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

CN(1)