LymphomaNCT05907447
A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types
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 retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas 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, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Oct 2024
- 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
- 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; Or patients newly diagnosed with non-Hodgkin lymphoma of rare pathological types, including IVLBCL, SMZL, ALCL, AITL, MALTL.
- 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
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Weili Zhao, zwl_trial@163.com
About this study
The aim of this study is to retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas in the real-world population.
Read the detailed description
Lymphoma is a highly common malignant tumor in Asia. For specific extra-abdominal sites or rare pathological subtypes of lymphoma, traditional chemotherapy protocols often cannot provide satisfactory results for patients. This study aims to retrospectively collect clinical information on patients with extranodal lymphoma or rare pathological subtype lymphoma, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the best treatment strategy for these lymphomas in the real-world population.
- Conditions
- Lymphoma, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Marginal Zone Lymphoma
- Being tested
- No interventions need to be specified for this study
- Keywords
- LYMPHOMA, EXTRANODAL
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Extranodal NK-T-Cell
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: 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: Baseline up to data cut-off (up to approximately 1 year)
Secondary outcomes (2)
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)
Biological characteristics form
Biological characteristics from data filled into registry forms by physicians and data managers, such as immunohistochemical differences and genetic mutation characteristics of non-hodgkin´s lymphomas.
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 posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Oct 2024 (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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking University Third Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Beijing Hospital, The Second Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Guangzhou Medical University, Henan Provincial People's Hospital, Hunan Cancer Hospital, Henan Cancer Hospital, The First Hospital of Jilin University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, The First Affiliated Hospital of Xiamen University, Shandong Provincial Hospital, Shanxi Province Cancer Hospital, RenJi Hospital, Beijing Friendship Hospital, West China Hospital, The First Affiliated Hospital of Soochow University, Tongji Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sun Yat-sen University, Chongqing University Cancer Hospital, Anhui Provincial Cancer Hospital, The General Hospital of Northern Theater Command, Qilu Hospital of Shandong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital Of Guizhou Medical University, Wuhan TongJi Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital with Nanjing Medical University, Anshan Central Hospital, Hainan Cancer Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Harbin Medical University, Zhujiang Hospital
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907447
- Sponsor's protocol ID
- EXPECT-01
- Status last verified
- Jun 2023
- First submitted
- 1 May 2023
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types
- ClinicalTrials.gov ID
- NCT05907447
- Acronym / sponsor ID
- EXPECT-01
- Conditions
- Lymphoma, Extranodal Lymphoma, Diffuse Large B Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Marginal Zone Lymphoma
- Keywords
- LYMPHOMA, EXTRANODAL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking University Third Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Beijing Hospital, The Second Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Guangzhou Medical University, Henan Provincial People's Hospital, Hunan Cancer Hospital, Henan Cancer Hospital, The First Hospital of Jilin University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, The First Affiliated Hospital of Xiamen University, Shandong Provincial Hospital, Shanxi Province Cancer Hospital, RenJi Hospital, Beijing Friendship Hospital, West China Hospital, The First Affiliated Hospital of Soochow University, Tongji Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sun Yat-sen University, Chongqing University Cancer Hospital, Anhui Provincial Cancer Hospital, The General Hospital of Northern Theater Command, Qilu Hospital of Shandong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital Of Guizhou Medical University, Wuhan TongJi Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital with Nanjing Medical University, Anshan Central Hospital, Hainan Cancer Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Harbin Medical University, Zhujiang Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 18 Jun 2023 (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 retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas in the real-world population.
Detailed description
Lymphoma is a highly common malignant tumor in Asia. For specific extra-abdominal sites or rare pathological subtypes of lymphoma, traditional chemotherapy protocols often cannot provide satisfactory results for patients. This study aims to retrospectively collect clinical information on patients with extranodal lymphoma or rare pathological subtype lymphoma, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the best treatment strategy for these lymphomas in the real-world population.
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 (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; Or patients newly diagnosed with non-Hodgkin lymphoma of rare pathological types, including IVLBCL, SMZL, ALCL, AITL, MALTL.
- 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
Overall Survival (OS)
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: 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.
2 secondary outcomes
Clinical characteristics form
Time frame: Baseline up to data cut-off (up to approximately 1 year)
Biological characteristics form
Time frame: Baseline up to data cut-off (up to approximately 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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. This study is not recruiting at the moment.
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 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: status not confirmed, as of the sponsor's last update on 18 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Prof. Zhao (+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?
Overall Survival (OS) (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 18 Jun 2023.