Correlation Between Driver Gene Abnormalities and Clinico... | NCT04263935

Studies
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

NCT04263935

Sponsor

Henan Cancer Hospital

Status

Recruiting

Last Update Posted

Apr 23, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Lymphoma
Gene Abnormality

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

Apr 2025

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

Jan 3, 2019Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 8, 2020

First Posted Date

Feb 11, 2020Actual

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

Apr 18, 2025

Last Update Posted Date

Apr 23, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Detailed Description

This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of driver gene abnormalities	the incidence of driver gene abnormalities by fixed gene testing technology	from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
objective response rate	the total proportion of patients with complete response (CR) and partial response (PR)	from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
5-year overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as lymphoma (according to WHO 2017 classification criteria)
Life expectancy no less than 3 months
Agreeing to sign the written informed consents

Exclusion Criteria:

Other malignant tumor history or active malignant tumor need be treated
Researchers determine unsuited to participate in this trial

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

Including demographic characteristics / clinical characteristics / pathological characteristics / treatment and efficacy evaluations.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanyan Liu, M.D. Ph.D	Contact	+8613818176375		yyliu@zzu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanyan Liu, M.D. Ph.D	Henan Cancer Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Recruiting	Zhengzhou	Henan		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided