LymphomaNCT06549361
A Retrospective Study on Extranodal DLBCL
An observational study of Lymphoma and Extranodal Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- How many people
- 5,023 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Sep 2023
- 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: Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.
Who may be able to join
- 1. ≥ 18 years (including 18 years).
- 2. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.
- 3. Newly diagnosed DLBCL with involvement of extranodal organs.
- 4. Patients who have received clinical treatment for lymphoma.
- 5.Patients with measurable lesions, including at least one effective efficacy assessment.
Who cannot join
- 1. Patients receiving supportive care only.
- 2. Patients who cannot obtain effective efficacy assessment data.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
Official title: The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma
The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.
Read the detailed description
DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.
- Conditions
- Lymphoma, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- No interventions need to be specified for this study
- Keywords
- Lymphoma, Extranodal
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions need to be specified for this studyOther
No interventions need to be specified for this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.
Measured: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Progression Free Survival (PFS)
Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Measured: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Secondary outcomes (1)
Clinical characteristics form
Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations.
Measured: Baseline up to data cut-off (up to approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 May 2022
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
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 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
- Retrospective
- Enrolment
- 5,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549361
- Sponsor's protocol ID
- ENI-DLBCL
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06549361
- Acronym / sponsor ID
- ENI-DLBCL
- Conditions
- Lymphoma, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- Keywords
- Lymphoma, Extranodal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,023 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 Aug 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 prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.
Detailed description
DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.
Key inclusion criteria (5 listed)
- 1. ≥ 18 years (including 18 years).
- 2. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.
- 3. Newly diagnosed DLBCL with involvement of extranodal organs.
- 4. Patients who have received clinical treatment for lymphoma.
- 5.Patients with measurable lesions, including at least one effective efficacy assessment.
Key exclusion criteria (2 listed)
- 1. Patients receiving supportive care only.
- 2. Patients who cannot obtain effective efficacy assessment data.
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 |
|---|---|---|
| No interventions need to be specified for this studyNo interventions need to be specified for this study | Other | – |
Primary outcome
Overall Survival (OS)
Time frame: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.
Progression Free Survival (PFS)
Time frame: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
1 secondary outcome
Clinical characteristics form
Time frame: Baseline up to data cut-off (up to approximately 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Extranodal 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 5 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: finished, as of the sponsor's last update on 12 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Time Frame: Baseline up to data cut-off (up to approximately 1 year)). The study lists 2 primary outcomes in all. 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 Aug 2024.