LymphomaNCT06203652
The Pathogenesis and Prognostic Factors of Lymphoma
An observational study of Lymphoma and Hodgkin Lymphoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- What is being tested?
- Real-world regimen
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 31 Dec 2028
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathological diagnosis of lymphoma from 2007 to 2027 according to 2016 WHO classification.
Who may be able to join
- Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
- Patients with complete diagnostic, treatment and follow-up records.
- Fully comprehension and signature of the informed consent form (ICF) for participation.
Who cannot join
- Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
- Severe mental illness.
- Patients deemed unsuitable for inclusion by the investigator.
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
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, Ph.D, +862164041990 ext. 2025, liu.peng@zs-hospital.sh.cn
Peng Liu, Ph.D
About this study
The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.
Read the detailed description
Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
- Conditions
- Lymphoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Being tested
- Real-world regimen
- Keywords
- lymphoma, Hodgkin lymphoma, Non-Hodgkin lymphoma, THRLBCL, DLBCL, MZL, CLL/SLL, MCL, WM
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-world regimenOther
The final personalized management strategy is determined based on current conventional treatment options, physician and patient preferences.The following protocols: chemotherapy, immunochemotherapy,Anti-cd20 monoclonal antibody, BTKi and so on
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | All patients who are eligible for participation to the study. Receives: Other: Real-world regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS) refers to the time from receiving the first dose to death from any cause
Measured: Baseline up to data cut-off (Up to approximately 20 years)
Secondary outcomes (1)
PFS
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.
Measured: Baseline up to data cut-off (Up to approximately 20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start5 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203652
- Sponsor's protocol ID
- SHZS-lym-001
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenesis and Prognostic Factors of Lymphoma
- ClinicalTrials.gov ID
- NCT06203652
- Acronym / sponsor ID
- SHZS-lym-001
- Conditions
- Lymphoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Keywords
- lymphoma, Hodgkin lymphoma, Non-Hodgkin lymphoma, THRLBCL, DLBCL, MZL, CLL/SLL, MCL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jan 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 aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.
Detailed description
Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | – | Other: Real-world regimenAll patients who are eligible for participation to the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathological diagnosis of lymphoma from 2007 to 2027 according to 2016 WHO classification.
Key inclusion criteria (3 listed)
- Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
- Patients with complete diagnostic, treatment and follow-up records.
- Fully comprehension and signature of the informed consent form (ICF) for participation.
Key exclusion criteria (3 listed)
- Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
- Severe mental illness.
- Patients deemed unsuitable for inclusion by the investigator.
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 |
|---|---|---|
| Real-world regimenThe final personalized management strategy is determined based on current conventional treatment options, physician and patient preferences.The following protocols: chemotherapy, immunochemotherapy,Anti-cd20 monoclonal antibody, BTKi and so on | Other | All enrolled patients |
Primary outcome
OS
Time frame: Baseline up to data cut-off (Up to approximately 20 years)
Overall survival (OS) refers to the time from receiving the first dose to death from any cause
1 secondary outcome
PFS
Time frame: Baseline up to data cut-off (Up to approximately 20 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 12 Jan 2024.
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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.
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 Lymphoma and Hodgkin Lymphoma, run by Shanghai Zhongshan 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 3 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 12 Jan 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?
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 Peng Liu, Ph.D (+862164041990 ext. 2025, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Baseline up to data cut-off (Up to approximately 20 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 12 Jan 2024.