LymphomaNCT06573099
A Real-World Study on Extranodal Lymphoma
An observational study of Lymphoma and Lymphoma, B-Cell, run by Ruijin Hospital.
Trial summary
The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2029
- 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
- Adult, Older adult
Study population: Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement.
Who may be able to join
- Age ≥ 18 years (including 18 years old).
- Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined.
- Patients who have received systematic clinical treatment.
- Patients with measurable lesions, at least containing one effective evaluation of efficacy.
Who cannot join
- Patients who only receive supportive treatment.
- Patients who cannot obtain effective evaluation data of efficacy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.
Read the detailed description
Lymphoma is a common hematological malignancy. Many different pathologic types of lymphoma can originate in extranodal organs or be associated with extranodal organ involvement. For lymphoma with extranodal involvement, conventional regimens often cannot provide satisfactory results for patients. This study aims to prospectively collect clinical information on patients with extranodal DLBCL, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the the best therapeutic strategies in the real-world population.
- Conditions
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- No interventions need to be specified for this study
- Keywords
- LYMPHOMA, EXTRANODAL, DLBCL
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, 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.
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: Baseline up to data cut-off (up to approximately 1 year)
Secondary outcomes (1)
Overall Survival (OS)
Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.
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 posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2029 (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 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
- 5,000 participants (estimated)
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
- NCT06573099
- Sponsor's protocol ID
- EXPECT-02
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on Extranodal Lymphoma
- ClinicalTrials.gov ID
- NCT06573099
- Acronym / sponsor ID
- EXPECT-02
- Conditions
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- Keywords
- LYMPHOMA, EXTRANODAL, DLBCL
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 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 on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.
Detailed description
Lymphoma is a common hematological malignancy. Many different pathologic types of lymphoma can originate in extranodal organs or be associated with extranodal organ involvement. For lymphoma with extranodal involvement, conventional regimens often cannot provide satisfactory results for patients. This study aims to prospectively collect clinical information on patients with extranodal DLBCL, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the the best therapeutic strategies in the real-world population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement.
Key inclusion criteria (4 listed)
- Age ≥ 18 years (including 18 years old).
- Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined.
- Patients who have received systematic clinical treatment.
- Patients with measurable lesions, at least containing one effective evaluation of efficacy.
Key exclusion criteria (2 listed)
- Patients who only receive supportive treatment.
- Patients who cannot obtain effective evaluation data of efficacy.
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
Progression Free Survival (PFS)
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
Overall Survival (OS)
Time frame: Baseline up to data cut-off (up to approximately 1 year)
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 27 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Lymphoma, B-Cell, run by Ruijin Hospital.
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 4 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: opening soon, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Baseline up to data cut-off (up to approximately 1 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 27 Aug 2024.