Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
- Conditions
- Plasma Cell Disorder
- Registration Number
- NCT06330896
- Lead Sponsor
- Siriraj Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 498
- 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
- Patients with missing crucial data that renders them unanalyzable
- Patients who refuse to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method genetic landscape of PCD 18 months in 498 patients number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders
- Secondary Outcome Measures
Name Time Method overall survival 18 months time of survival in MM patients
progression free survival 18 months time of disease progression in MM patients
gender 18 months in 498 patients number and percentage of male and female
age 18 months in 498 patients age in years
genetic correlation 18 months in MM patients genetic landscape correlation between FISH and NGS in MM patients
factor of genetic landscape differentiation 18 months in MM patients number of MM patients who have the different factors such as gender, age, and comorbidities.
genetic landscape of relapse MM patients 18 months in MM patients number of genetic landscape in relapse MM patients