A Retrospective Cohort Study: Influence of MTHFR C677T an... | NCT04469543

Studies
A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma

NCT04469543

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Jul 14, 2020Actual

Enrollment

374Actual

Phase

Not provided

Conditions

Pediatric Non-Hodgkin 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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2014Actual

Primary Completion Date

Feb 6, 2020Actual

Completion Date

May 20, 2020Actual

First Submitted Date

Jul 9, 2020

First Submission Date that Met QC Criteria

Jul 9, 2020

First Posted Date

Jul 14, 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

Jul 9, 2020

Last Update Posted Date

Jul 14, 2020Actual

Description Module

Brief Summary

The primary purpose of this retrospective study was to investigate the influence of methylenetetrahydrofolate reductase (MTHFR) C677T/A1298C polymorphism on the survival of pediatric patients with Non-Hodgkin lymphoma (NHL) treated with modified NHL-BFM95 protocol in south China.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

374Actual

Label	Type	Description	Intervention Names
MTHFR polymorphism

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	Overall survival time was calculated from the time of initial diagnosis to death	About six years
Events including progression, relapse, and secondary cancer	Event-free survival (EFS) time was calculated from the time of initial diagnosis to first event.	About six years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged ≤ 18 years;
newly diagnosed as the four main categories of NHL(Burkitt's lymphoma, lymphoblastic lymphoma, anaplastic large cell lymphoma, and diffuse large B-cell lymphoma) between 2014 and 2020;
treated according to the modified BFM95 protocol.

Exclusion Criteria:

aged > 18 years;
not newly diagnosed as the four main categories of NHL between 2014 and 2020;
treated according to chemotherapeutic regimens except for the modified BFM95 protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

We reviewed all the medical records of the patients who met the inclusion criteria in Sun Yat-sen University Cancer Center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen University Cancer Center		Guangzhou	Guangdong	510060	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided