Multiple MyelomaNCT06302699
Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma
An observational study of Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Multiple myeloma patients with baseline and sequential next-generation flow-MRD data are included in this study.
Who may be able to join
- Subjects diagnosed with MM.
- With available baseline and sequential next-generation flow-MRD data.
Who cannot join
- Subjects without baseline and sequential next-generation flow-MRD data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
InsituteHBDH
Tianjin, Tianjin Municipality, 300020
Gang An, PhD&MD, 222-390-9095, angang@ihcams.ac.cn
Gang An, PhD&MD
About this study
Official title: Clinical Utility of Ultrasensitive Chromosomal Aberrations Detection (UCAD) for Detecting Minimal Residual Disease (MRD) and Monitoring Clonal Evolution by Low-Pass Whole Genome Sequencing in Multiple Myeloma
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.
- Conditions
- Multiple Myeloma
- Keywords
- Minimal Residual Disease, Low-Pass Whole Genome Sequencing, Clonal Evolution, Ultrasensitive Chromosomal Aberrations Detection
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of copy number variation
Measured: From May 1, 2023 to December 31, 2023
Secondary outcomes (1)
Serial monitoring of treatment response
Measured: From January 1, 2024 to May 31, 20224
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Hongyuan Biotech Inc., Biobay, Suzhou, China.
- Responsible party
- Principal investigator, Gang An, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302699
- Sponsor's protocol ID
- UCAD-MM-001
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.
PubMed 33037018
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Ultrasensitive Chromosomal Aberrations Detection (UCAD) for Detecting Minimal Residual Disease (MRD) and Monitoring Clonal Evolution by Low-Pass Whole Genome Sequencing in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06302699
- Acronym / sponsor ID
- UCAD-MM-001
- Conditions
- Multiple Myeloma
- Keywords
- Minimal Residual Disease, Low-Pass Whole Genome Sequencing, Clonal Evolution, Ultrasensitive Chromosomal Aberrations Detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Suzhou Hongyuan Biotech Inc., Biobay, Suzhou, China.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 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 presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple myeloma patients with baseline and sequential next-generation flow-MRD data are included in this study.
Key inclusion criteria (2 listed)
- Subjects diagnosed with MM.
- With available baseline and sequential next-generation flow-MRD data.
Key exclusion criteria (1 listed)
- Subjects without baseline and sequential next-generation flow-MRD data.
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
Detection of copy number variation
Time frame: From May 1, 2023 to December 31, 2023
1 secondary outcome
Serial monitoring of treatment response
Time frame: From January 1, 2024 to May 31, 20224
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 33037018Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang An, PhD&MD (008613502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of copy number variation (time frame: From May 1, 2023 to December 31, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302699, which also lists 1 linked publication.
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 12 Mar 2024.