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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03313271
Other study ID # h-yx-bj-16003
Secondary ID
Status Recruiting
Phase N/A
First received October 11, 2017
Last updated October 17, 2017
Start date May 17, 2017
Est. completion date August 30, 2027

Study information

Verified date October 2017
Source Peking University
Contact Yuqin Song, Ph D
Phone 0086 ?13683398726?
Email songyuqin622@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date August 30, 2027
Est. primary completion date May 17, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- There are no special exclusion criteria in this study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (6)

Lead Sponsor Collaborator
Jun Zhu Heilongjiang Cancer Hospital, Peking University First Hospital, Sipai(Beijing)Network Technology Co Ltd, Tianjin Medical University Cancer Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Australian 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. — View Citation

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. — View Citation

De 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. — View Citation

Zeng 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 years
Secondary Overall survival Overall survival is defined as the time from disease to death 10 years
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