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

NCT06330896 | Not Yet Recruiting

• 1 other identifier: 346/2566(IRB3)
• Study Type: observational
• Target: 498
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plasma Cell Disorder

Keywords

Plasma Cell Disorder; genetic abnormalities; Fluorescence In Situ Hybridization; FISH; Next Generation Sequencing; NGS

Outcome Measures

Primary Outcomes (1)

• genetic landscape of PCD

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

  18 months in 498 patients

Secondary Outcomes (7)

• genetic correlation

  18 months in MM patients

• genetic landscape of relapse MM patients

  18 months in MM patients

• overall survival

  18 months

• progression free survival

  18 months

• factor of genetic landscape differentiation

  18 months in MM patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Siriraj Hospital: lead

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Chutima Kunacheewa

CONTACT

66896790959; chutima.kua@mahidol.ac.th

Weerapat Owattanapanich

CONTACT

66891081983; weerapat.owa@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: April 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 26, 2024

Record last verified: 2024-03