Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:

* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing * genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients. * disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS. * correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.

The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis

Aged 18 years and older

Performed FISH and/or NGS testing

Has treatment follow up at least one year

Disqualifiers

Patients with missing crucial data that renders them unanalyzable

Patients who refuse to participate in the study

Trial population

patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis who were performed FISH and/or NGS testing

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

genetic landscape of PCD

number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders

Time frame
18 months in 498 patients

Secondary outcomes

1

genetic correlation

genetic landscape correlation between FISH and NGS in MM patients

Time frame
18 months in MM patients
2

genetic landscape of relapse MM patients

number of genetic landscape in relapse MM patients

Time frame
18 months in MM patients
3

overall survival

time of survival in MM patients

Time frame
18 months
4

progression free survival

time of disease progression in MM patients

Time frame
18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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