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NCT Number: NCT06330896

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. genetic landscape of PCD

    Time frame: 18 months in 498 patients

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

Secondary outcomes

  1. genetic correlation

    Time frame: 18 months in MM patients

    genetic landscape correlation between FISH and NGS in MM patients

  2. genetic landscape of relapse MM patients

    Time frame: 18 months in MM patients

    number of genetic landscape in relapse MM patients

  3. overall survival

    Time frame: 18 months

    time of survival in MM patients

  4. progression free survival

    Time frame: 18 months

    time of disease progression in MM patients

  5. factor of genetic landscape differentiation

    Time frame: 18 months in MM patients

    number of MM patients who have the different factors such as gender, age, and comorbidities.

  6. gender

    Time frame: 18 months in 498 patients

    number and percentage of male and female

  7. age

    Time frame: 18 months in 498 patients

    age in years

Study contacts

Contact information is provided by the study sponsor or research team.

Chutima Kunacheewa

CONTACT

[email protected]

66896790959

Weerapat Owattanapanich

CONTACT

[email protected]

66891081983

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Acronym: genetics MM

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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