Plasma Cell Disordergenetics MMNCT06330896
Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
An observational study of Plasma Cell Disorder, run by Siriraj Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Disorder
- How many people
- 498 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis who were performed FISH and/or NGS testing
Who may be able to join
- 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
Who cannot join
- Patients with missing crucial data that renders them unanalyzable
- Patients who refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Neoplasms, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic landscape of PCD
number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders
Measured: 18 months in 498 patients
Secondary outcomes (7)
genetic correlation
genetic landscape correlation between FISH and NGS in MM patients
Measured: 18 months in MM patients
genetic landscape of relapse MM patients
number of genetic landscape in relapse MM patients
Measured: 18 months in MM patients
overall survival
time of survival in MM patients
Measured: 18 months
progression free survival
time of disease progression in MM patients
Measured: 18 months
factor of genetic landscape differentiation
number of MM patients who have the different factors such as gender, age, and comorbidities.
Measured: 18 months in MM patients
gender
number and percentage of male and female
Measured: 18 months in 498 patients
age
age in years
Measured: 18 months in 498 patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutima Kunacheewa, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330896
- Sponsor's protocol ID
- 346/2566(IRB3)
- Acronym
- genetics MM
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need a consensus from colleagues
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06330896
- Acronym / sponsor ID
- genetics MM / 346/2566(IRB3)
- Conditions
- Plasma Cell Disorder
- Keywords
- Plasma Cell Disorder, genetic abnormalities, Fluorescence In Situ Hybridization, FISH, Next Generation Sequencing, NGS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis who were performed FISH and/or NGS testing
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with missing crucial data that renders them unanalyzable
- Patients who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
genetic correlation
Time frame: 18 months in MM patients
genetic landscape of relapse MM patients
Time frame: 18 months in MM patients
overall survival
Time frame: 18 months
progression free survival
Time frame: 18 months
factor of genetic landscape differentiation
Time frame: 18 months in MM patients
gender
Time frame: 18 months in 498 patients
age
Time frame: 18 months in 498 patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Undecided. Need a consensus from colleagues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Disorder, run by Siriraj Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chutima Kunacheewa (66896790959, chutima.kua@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic landscape of PCD (time frame: 18 months in 498 patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.