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

July 9, 2020 updated by: Xiao-Fei Sun, Sun Yat-sen University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

374

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. aged ≤ 18 years;
  2. 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;
  3. treated according to the modified BFM95 protocol.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MTHFR polymorphism

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2014

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

May 20, 2020

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCCG-NHL2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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