China Lymphoma Patient Registry Study | NCT03313271

Studies
China Lymphoma Patient Registry Study

NCT03313271

Sponsor

Jun Zhu

Status

Recruiting

Last Update Posted

Oct 18, 2017Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Lymphoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2017Actual

Primary Completion Date

May 17, 2027Estimated

Completion Date

Aug 30, 2027Estimated

First Submitted Date

Oct 11, 2017

First Submission Date that Met QC Criteria

Oct 17, 2017

First Posted Date

Oct 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2017

Last Update Posted Date

Oct 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Zhu, Director of lymphoma department, Peking UniversitySponsor-Investigator

Lead Sponsor

Jun ZhuOTHER

Collaborators

Name	Class
Peking University First Hospital	OTHER
Tianjin Medical University Cancer Hospital	UNKNOWN
Zhejiang Cancer Hospital	OTHER
Heilongjiang Provicial Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival is defined as the time from disease to death	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lymphoma patients in 5 hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuqin Song, Ph D	Contact	0086 ‭13683398726‬		songyuqin622@163.com

Overall Officials

Name	Affiliation	Role
Jun Zhu, Ph D	Peking University Cancer Hospital & Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26808342	Background	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.
25242378	Background	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.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases