LymphomaCLAPNCT03313271
China Lymphoma Patient Registry Study
An observational study of Lymphoma, run by Jun Zhu at 1 site in China.
Trial summary
Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2017to 30 Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lymphoma patients in 5 hospitals
Who may be able to join
- The disease was diagnosed by Hodgkin's or non Hodgkin's lymphoma
- 18 years of age or older at diagnosis
- The diagnosis was confirmed within 6 months before admission
- Informed consent was obtained
Who cannot join
- There are no special exclusion criteria in this study
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
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Ph D, 13683398726, songyuqin622@163.com
About this study
Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.
Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.
Read the detailed description
Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.
Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.
- Conditions
- Lymphoma
- Keywords
- lymphoma, CLAP, China, patient registry
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a cohort of patients with lymphoma in China | establish a cohort of patients with lymphoma in China and follow up the patients for a long period of time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of lymphoma in China，
Understand the characteristics of lymphoma in China,such as the distribution of sex,age,histological type and clinical stage etc
Measured: 5 years
Secondary outcomes (1)
Overall survival
Overall survival is defined as the time from disease to death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start17 May 2017
- Primary completion17 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jun Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Cancer Hospital, Heilongjiang Provicial Hospital, Sipai(Beijing)Network Technology Co Ltd
- Responsible party
- Sponsor-investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, Ph D, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313271
- Sponsor's protocol ID
- h-yx-bj-16003
- Acronym
- CLAP
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Zeng H, Zheng R, Guo Y, Zhang S, Zou X, Wang N, Zhang L, Tang J, Chen J, Wei K, Huang S, Wang J, Yu L, Zhao D, Song G, Chen J, Shen Y, Yang X, Gu X, Jin F, Li Q, Li Y, Ge H, Zhu F, Dong J, Guo G, Wu M, Du L, Sun X, He Y, Coleman MP, Baade P, Chen W, Yu XQ. Cancer survival in China, 2003-2005: a population-based study. Int J Cancer. 2015 Apr 15;136(8):1921-30. doi: 10.1002/ijc.29227. Epub 2014 Oct 3.
PubMed 25242378De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M, Engholm G, Nennecke A, Siesling S, Berrino F, Capocaccia R; EUROCARE-5 Working Group. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE--5-a population-based study. Lancet Oncol. 2014 Jan;15(1):23-34. doi: 10.1016/S1470-2045(13)70546-1. Epub 2013 Dec 5.
PubMed 24314615Australian Institute of Health and Welfare. Cancer survival and prevalence in Australia: period estimates from 1982 to 2010. Asia Pac J Clin Oncol. 2013 Mar;9(1):29-39. doi: 10.1111/ajco.12062.
PubMed 23418847
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Lymphoma Patient Registry Study
- ClinicalTrials.gov ID
- NCT03313271
- Acronym / sponsor ID
- CLAP / h-yx-bj-16003
- Conditions
- Lymphoma
- Keywords
- lymphoma, CLAP, China, patient registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Jun ZhuUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Cancer Hospital, Heilongjiang Provicial Hospital, Sipai(Beijing)Network Technology Co Ltd
- Study start
- 17 May 2017 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 18 Oct 2017 (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.
Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.
Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.
Detailed description
Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.
Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a cohort of patients with lymphoma in China | – | –establish a cohort of patients with lymphoma in China and follow up the patients for a long period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lymphoma patients in 5 hospitals
Key inclusion criteria (4 listed)
- The disease was diagnosed by Hodgkin's or non Hodgkin's lymphoma
- 18 years of age or older at diagnosis
- The diagnosis was confirmed within 6 months before admission
- Informed consent was obtained
Key exclusion criteria (1 listed)
- There are no special exclusion criteria in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of lymphoma in China，
Time frame: 5 years
Understand the characteristics of lymphoma in China,such as the distribution of sex,age,histological type and clinical stage etc
1 secondary outcome
Overall survival
Time frame: 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 18 Oct 2017.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 25242378Zeng H, Zheng R, Guo Y, Zhang S, Zou X, Wang N, Zhang L, Tang J, Chen J, Wei K, Huang S, Wang J, Yu L, Zhao D, Song G, Chen J, Shen Y, Yang X, Gu X, Jin F, Li Q, Li Y, Ge H, Zhu F, Dong J, Guo G, Wu M, Du L, Sun X, He Y, Coleman MP, Baade P, Chen W, Yu XQ. Cancer survival in China, 2003-2005: a population-based study. Int J Cancer. 2015 Apr 15;136(8):1921-30. doi: 10.1002/ijc.29227. Epub 2014 Oct 3.
- Background: PubMed 24314615De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M, Engholm G, Nennecke A, Siesling S, Berrino F, Capocaccia R; EUROCARE-5 Working Group. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE--5-a population-based study. Lancet Oncol. 2014 Jan;15(1):23-34. doi: 10.1016/S1470-2045(13)70546-1. Epub 2013 Dec 5.
- Background: PubMed 23418847Australian Institute of Health and Welfare. Cancer survival and prevalence in Australia: period estimates from 1982 to 2010. Asia Pac J Clin Oncol. 2013 Mar;9(1):29-39. doi: 10.1111/ajco.12062.
- 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.
Jun Zhu, Ph D principal investigator
Peking University Cancer Hospital & Institute
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, run by Jun Zhu 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 1 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 18 Oct 2017. 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 Yuqin Song, Ph D (0086 13683398726, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of lymphoma in China， (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313271, which also lists 4 linked publications.
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 Oct 2017.