Mature B-Cell LymphomaNCT04088422
Cell Free DNA in Mature B-cell Lymphoma
An observational study of Mature B-Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mature B-Cell Lymphoma
- What is being tested?
- peripheral blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to Dec 2026
- 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 diagnosis of mature B-cell tumor according to WHO 2008 criteria without any previous treatment in Ruijin Hospital would be included.
Who may be able to join
- Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
- 18 years or older
Who cannot join
- Chemotherapy before
- Other tumors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, Shanghai Municipality, 200025
Pengpeng XU, MD, PhD, 86-21-64370045 ext. 610707, xpproc@msn.com
Weili ZHAO, MD, PhD
About this study
Official title: Prospective, Observational Study on Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Lymphoma Management
The purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution.
- Conditions
- Mature B-Cell Lymphoma
- Being tested
- peripheral blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral blood collectionProcedure or surgery
peripheral blood collection at treatment start, interm PET/CT, end of treatment PET/CT, one-year and two-year follow-up and or progression or relapse
| Study group | Role | What they receive |
|---|---|---|
| B-cell lymphoma | Not described Receives: Procedure: peripheral blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 2-year
Secondary outcomes (2)
overall survival
Measured: 2-year
Complete Response rate
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start28 Sep 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, MD，PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088422
- Sponsor's protocol ID
- cfDNA
- Status last verified
- Feb 2023
- First submitted
- 11 Sep 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study on Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Lymphoma Management
- ClinicalTrials.gov ID
- NCT04088422
- Acronym / sponsor ID
- cfDNA
- Conditions
- Mature B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Sep 2019 (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 purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-cell lymphoma | – | Procedure: peripheral blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of mature B-cell tumor according to WHO 2008 criteria without any previous treatment in Ruijin Hospital would be included.
Key inclusion criteria (2 listed)
- Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
- 18 years or older
Key exclusion criteria (2 listed)
- Chemotherapy before
- Other 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 |
|---|---|---|
| peripheral blood collectionperipheral blood collection at treatment start, interm PET/CT, end of treatment PET/CT, one-year and two-year follow-up and or progression or relapse | Procedure or surgery | B-cell lymphoma |
Primary outcome
progression free survival
Time frame: 2-year
2 secondary outcomes
overall survival
Time frame: 2-year
Complete Response rate
Time frame: 6 weeks after treatment
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 24 Feb 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.
Weili Zhao, MD，PhD principal investigator
Ruijin Hospital
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 Mature B-Cell Lymphoma, run by Ruijin Hospital 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 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: looking for participants now, as of the sponsor's last update on 24 Feb 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?
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 Weili Zhao, MD，PhD (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 2-year). 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 24 Feb 2023.