The Pathogenesis and Prognostic Factors of Lymphoma | NCT06203652

Studies
The Pathogenesis and Prognostic Factors of Lymphoma

NCT06203652

Sponsor

Shanghai Zhongshan Hospital

Status

Recruiting

Last Update Posted

Jan 12, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Lymphoma
Hodgkin Lymphoma
Non-hodgkin Lymphoma

Interventions

Real-world regimen

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

Jan 2024

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

Jun 5, 2023Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jan 2, 2024

First Submission Date that Met QC Criteria

Jan 2, 2024

First Posted Date

Jan 12, 2024Actual

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

Jan 2, 2024

Last Update Posted Date

Jan 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.

Detailed Description

Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All enrolled patients		All patients who are eligible for participation to the study.	Other: Real-world regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Real-world regimen	Other	The final personalized management strategy is determined based on current conventional treatment options, physician and patient preferences.The following protocols: chemotherapy, immunochemotherapy,Anti-cd20 monoclonal antibody, BTKi and so on

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OS	Overall survival (OS) refers to the time from receiving the first dose to death from any cause	Baseline up to data cut-off (Up to approximately 20 years)

Secondary Outcomes

Measure	Description	Time Frame
PFS	Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.	Baseline up to data cut-off (Up to approximately 20 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
Patients with complete diagnostic, treatment and follow-up records.
Fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
Severe mental illness.
Patients deemed unsuitable for inclusion by the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with pathological diagnosis of lymphoma from 2007 to 2027 according to 2016 WHO classification.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peng Liu, Ph.D	Contact	+862164041990	2025	liu.peng@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital，Fudan University	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

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

Browse Leaves

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Browse Branches

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