Marginal Zone LymphomaNCT06449885
A Cohort Study in Newly Diagnosed MZL
An observational study of Marginal Zone Lymphoma, run by Fudan University at 1 site in China.
Trial summary
Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- patients receive optimal treatment or follow-up according to the characteristics of the disease
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 30 Jun 2034
- 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 newly diagnosed marginal zone lymphoma who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol.
Who may be able to join
- Age≥ 18 years old; Male or female.
- Newly diagnosed marginal zone lymphoma by histopathology within the past 6 months (180 days) and no anti-tumor therapy (including chemotherapy, radiotherapy, and biological therapy or immunotherapy for the treatment of tumors).
- Willing to provide biological samples required for the study, including blood samples and tumor tissue.
- Voluntarily join this study and sign the informed consent form.
- Willing to accept long-term follow-up.
Who cannot join
- Patients with HIV infection.
- Those who cannot come to the hospital regularly for follow-up.
- Those with comorbidities and speech impairment.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Rong Tao, MD, 8621-64175590, rtao@shca.org.cn
Yizhen Liu, MD, 8621-64175590, aliuyz@126.com
About this study
Official title: A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma
Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities.
Read the detailed description
Marginal zone lymphoma (MZL) originates from the marginal zone of lymphatic follicles and can occur in the spleen, lymph nodes and mucosal lymphoid tissues, and the incidence increases with age. The clinicopathological features of each subtype of MZL are heterogeneous, and their clinical manifestations, biology, etiology, and treatment are all quite heterogeneous, and there is still significant uncertainty about the optimal treatment pathway. This prospective, multicenter, cohort study aims to describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of MZL, and to observe the therapeutic efficacy and safety of different treatment modalities.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- patients receive optimal treatment or follow-up according to the characteristics of the disease
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients receive optimal treatment or follow-up according to the characteristics of the diseaseOther
Patients with MZL who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol. This study does not specify a detailed treatment modality, and patients receive optimal treatment or follow-up according to the characteristics of the disease.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed marginal zone lymphoma | Newly diagnosed marginal zone lymphoma，including Mucosa-associated lymphoid tissue (MALT) lymphoma, spleen MZL, and lymph node MZL, as well as primary cutaneous MZL, and pediatric NMZL. Receives: Other: patients receive optimal treatment or follow-up according to the characteristics of the disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
record the period from date of patients sign informed consent until the date of documented progression or date of death from any cause, whichever came first
Measured: assessed up to 10 years
Secondary outcomes (7)
Time to treatment
calculate the time interval between the start of diagnosis and the first dose of anti-tumor therapy.
Measured: assessed up to 10 years
Time to next treatment
the time interval from initiation of treatment to initiation of next-line anti-neoplastic therapy or death due to any cause.
Measured: assessed up to 10 years
ORR
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Measured: up to 6 months
Overall survival
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Measured: assessed up to 10 years
Adverse events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: Throughout the treatment period, up to 10 years
Histologic transformation rate
Proportion of patients with histologic transformation in all patients
Measured: Throughout the study, up to 10 years
Occurrence rate of a second tumor
Proportion of patients with a second tumor in all patients
Measured: Throughout the study, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start30 May 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, M.D, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449885
- Sponsor's protocol ID
- SHCA-MZL-001
- Status last verified
- Nov 2025
- First submitted
- 30 May 2024
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06449885
- Acronym / sponsor ID
- SHCA-MZL-001
- Conditions
- Marginal Zone Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 10 Jun 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.
Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities.
Detailed description
Marginal zone lymphoma (MZL) originates from the marginal zone of lymphatic follicles and can occur in the spleen, lymph nodes and mucosal lymphoid tissues, and the incidence increases with age. The clinicopathological features of each subtype of MZL are heterogeneous, and their clinical manifestations, biology, etiology, and treatment are all quite heterogeneous, and there is still significant uncertainty about the optimal treatment pathway. This prospective, multicenter, cohort study aims to describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of MZL, and to observe the therapeutic efficacy and safety of different treatment modalities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed marginal zone lymphoma | – | Other: patients receive optimal treatment or follow-up according to the characteristics of the diseaseNewly diagnosed marginal zone lymphoma，including Mucosa-associated lymphoid tissue (MALT) lymphoma, spleen MZL, and lymph node MZL, as well as primary cutaneous MZL, and pediatric NMZL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed marginal zone lymphoma who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol.
Key inclusion criteria (5 listed)
- Age≥ 18 years old; Male or female.
- Newly diagnosed marginal zone lymphoma by histopathology within the past 6 months (180 days) and no anti-tumor therapy (including chemotherapy, radiotherapy, and biological therapy or immunotherapy for the treatment of tumors).
- Willing to provide biological samples required for the study, including blood samples and tumor tissue.
- Voluntarily join this study and sign the informed consent form.
- Willing to accept long-term follow-up.
Key exclusion criteria (3 listed)
- Patients with HIV infection.
- Those who cannot come to the hospital regularly for follow-up.
- Those with comorbidities and speech impairment.
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 |
|---|---|---|
| patients receive optimal treatment or follow-up according to the characteristics of the diseasePatients with MZL who are eligible for enrollment will be evaluated by the investigator and the enrolled patients will receive long-term follow-up after collecting medical history information, biological samples, and oncology data according to the study protocol. This study does not specify a detailed treatment modality, and patients receive optimal treatment or follow-up according to the characteristics of the disease. | Other | Newly diagnosed marginal zone lymphoma |
Primary outcome
Progression-free survival
Time frame: assessed up to 10 years
record the period from date of patients sign informed consent until the date of documented progression or date of death from any cause, whichever came first
7 secondary outcomes
Time to treatment
Time frame: assessed up to 10 years
Time to next treatment
Time frame: assessed up to 10 years
ORR
Time frame: up to 6 months
Overall survival
Time frame: assessed up to 10 years
Adverse events
Time frame: Throughout the treatment period, up to 10 years
Histologic transformation rate
Time frame: Throughout the study, up to 10 years
Occurrence rate of a second tumor
Time frame: Throughout the study, up to 10 years
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 19 Nov 2025.
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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.
Rong Tao, M.D study chair
Fudan University
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 Marginal Zone Lymphoma, run by Fudan University 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 5 inclusion and 3 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 19 Nov 2025. 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 Rong Tao, M.D (86-21-64175590, rtao@shca.org.cn), 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: assessed up to 10 years). 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 19 Nov 2025.