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The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

ConditionsMultiple MyelomaMonoclonal Gammopathy of Undetermined Significance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sample of Blood

    Diagnostic 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
2 Years
2

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.

Time frame
10 Years

Secondary outcomes

1

Overall survival of MGUS patients

The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive.

Time frame
10 Years
2

Quality of life (QoL) of MGUS patients

QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period.

Time frame
10 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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