Pediatric Non-Hodgkin LymphomaNCT04469543
A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma
An observational study of Pediatric Non-Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Non-Hodgkin Lymphoma
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2014to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We reviewed all the medical records of the patients who met the inclusion criteria in Sun Yat-sen University Cancer Center
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pediatric Non-Hodgkin Lymphoma
- Keywords
- MTHFR C677T polymorphism；A1298C; Pediatric Non-Hodgkin Lymphoma；Survival.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MTHFR polymorphism | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Overall survival time was calculated from the time of initial diagnosis to death
Measured: 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.
Measured: About six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start20 Jan 2014
- Primary completion6 Feb 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Fei Sun, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469543
- Sponsor's protocol ID
- SCCCG-NHL2017
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04469543
- Acronym / sponsor ID
- SCCCG-NHL2017
- Conditions
- Pediatric Non-Hodgkin Lymphoma
- Keywords
- MTHFR C677T polymorphism；A1298C; Pediatric Non-Hodgkin Lymphoma；Survival.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTHFR polymorphism | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We reviewed all the medical records of the patients who met the inclusion criteria in Sun Yat-sen University Cancer Center
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: About six years
Overall survival time was calculated from the time of initial diagnosis to death
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Non-Hodgkin Lymphoma
Recruiting
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Melanoma Stage III, B-cell Non Hodgkin Lymphoma
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma
RecruitingPhase 1
Study of SGR-1505 in Mature B-Cell Neoplasms
Mature B-Cell Neoplasm, Non Hodgkin Lymphoma
RecruitingPhase 1/2
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)
Relapsed Non Hodgkin Lymphoma, Relapsed Adult ALL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Non-Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: About six years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.