Multiple MyelomaNCT05693012
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
An observational study of Multiple Myeloma, run by Qiu Lugui at 1 site in China.
Trial summary
It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- cfDNA methylation assessment
- How many people
- 398 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2024
- 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 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Eligible participants will be recruited from the participating medical center and assigned into three arms, including participants with newly diagnosed multiple myeloma, benign hematologic disorders and healthy participants.
Who may be able to join
- Age 40-75 years
- Ability to provide a written informed consent
- Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
- No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw
- Age 40-75 years
- Ability to provide a written informed consent
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- Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders
- No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw
- Age 40-75 years
- Ability to provide a written informed consent
- No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw
Who cannot join
- Insufficient qualified blood samples
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
- Recipient of blood transfusion within 7 days prior to blood draw
- Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)
- Additional Exclusion Criteria for Cancer Participants:
- Other current malignant diseases or multiple primary tumors
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- Additional Exclusion Criteria for Benign Disease Participants:
- Current or history of malignancies
- Additional Exclusion Criteria for Healthy Participants:
- Recipient of anti-infectious therapy within 14 days prior to study blood draw
- Prior or ongoing treatment of cancer within 3 years prior to study blood draw
- Current autoimmune disease or clinically significant or uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
Mu Hao, Ph.D contact
China1 site, 1 recruiting
- Recruiting
National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020
Lugui Qiu, MD, Ph.D, 23909172, qiulg@ihcams.ac.cn
About this study
Official title: Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.
- Conditions
- Multiple Myeloma
- Being tested
- cfDNA methylation assessment
- Keywords
- multiple myeloma, early detection, liquid biopsy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA methylation assessmentDiagnostic test
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | participants with newly diagnosed multiple myeloma, from whom blood samples will be collected. Receives: Diagnostic Test: cfDNA methylation assessment | |
| Benign Arm | Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected. Receives: Diagnostic Test: cfDNA methylation assessment | |
| Healthy arm | Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. Receives: Diagnostic Test: cfDNA methylation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.
Measured: 12 months
Secondary outcomes (3)
The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.
Measured: 12 months
The performance of a cfDNA methylation-based prognostic model for multiple myeloma.
Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma.
Measured: 12 months
The specific cfDNA methylation landscape of multiple myeloma in China
The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiu Lugui
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor-investigator, Qiu Lugui, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Lugui Qiu, MD, Ph.D, Principal investigator, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693012
- Sponsor's protocol ID
- RSCD2022004
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT05693012
- Acronym / sponsor ID
- RSCD2022004
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, early detection, liquid biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Qiu LuguiUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jan 2023 (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.
It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Diagnostic Test: cfDNA methylation assessmentparticipants with newly diagnosed multiple myeloma, from whom blood samples will be collected. |
| Benign Arm | – | Diagnostic Test: cfDNA methylation assessmentParticipants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected. |
| Healthy arm | – | Diagnostic Test: cfDNA methylation assessmentParticipants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from the participating medical center and assigned into three arms, including participants with newly diagnosed multiple myeloma, benign hematologic disorders and healthy participants.
Key inclusion criteria (11 listed)
- Age 40-75 years
- Ability to provide a written informed consent
- Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
- No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw
- Age 40-75 years
Key exclusion criteria (12 listed)
- Insufficient qualified blood samples
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
- Recipient of blood transfusion within 7 days prior to blood draw
- Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)
- Other current malignant diseases or multiple primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cfDNA methylation assessmentAn exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment | Diagnostic test | Benign Arm, Cancer Arm, Healthy arm |
Primary outcome
The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.
Time frame: 12 months
3 secondary outcomes
The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.
Time frame: 12 months
The performance of a cfDNA methylation-based prognostic model for multiple myeloma.
Time frame: 12 months
The specific cfDNA methylation landscape of multiple myeloma in China
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
Mu Hao, Ph.D contact
Lugui Qiu, MD, Ph.D principal investigator
Chinese Academy of Medical Sciences & Peking Union Medical College
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 Qiu Lugui 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 11 inclusion and 12 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 20 Jan 2023. 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 Lugui Qiu, MD, Ph.D (23909172, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma. (time frame: 12 months). 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 20 Jan 2023.