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

NCT ID: NCT06330896

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-04-01

Brief Summary

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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

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Conditions

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Plasma Cell Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chutima Kunacheewa

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Chutima Kunacheewa

Role: CONTACT

66896790959

Weerapat Owattanapanich

Role: CONTACT

66891081983

Other Identifiers

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346/2566(IRB3)

Identifier Type: -

Identifier Source: org_study_id

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