NCT04469543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

6 years

First QC Date

July 9, 2020

Last Update Submit

July 9, 2020

Conditions

Pediatric Non-Hodgkin Lymphoma

Keywords

MTHFR C677T polymorphism；A1298C; Pediatric Non-Hodgkin Lymphoma；Survival.

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

MTHFR polymorphism

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

January 20, 2014

Primary Completion

February 6, 2020

Study Completion

May 20, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

CN(1)