Clinical trial NCT06330896: Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
Official title: Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Plasma Cell Disorder
Keywords: Plasma Cell Disorder
genetic abnormalities
Fluorescence In Situ Hybridization
FISH
Next Generation Sequencing
NGS
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis who were performed FISH and/or NGS testing

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with missing crucial data that renders them unanalyzable
* Patients who refuse to participate in the study

Primary outcomes:
measure: genetic landscape of PCD
timeFrame: 18 months in 498 patients
Secondary outcomes:
measure: genetic correlation
timeFrame: 18 months in MM patients
measure: genetic landscape of relapse MM patients
timeFrame: 18 months in MM patients
measure: overall survival
timeFrame: 18 months
measure: progression free survival
timeFrame: 18 months
measure: factor of genetic landscape differentiation
timeFrame: 18 months in MM patients
measure: gender
timeFrame: 18 months in 498 patients
measure: age
timeFrame: 18 months in 498 patients
Other outcomes:
Locations:
Study officials:
References: