Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

March 29, 2021 updated by: Junning Cao, MD, Fudan University

A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma

to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

  • Name: Qunling Zhang, PhD
  • Phone Number: 88900 +86-021-64175590
  • Email: zqldoc@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Qunling Zhang, PhD
          • Phone Number: 88900 +86-021-64175590
          • Email: zqldoc@163.com

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all new diagnosed DLBCL

Description

Inclusion Criteria:

  • ECOG PS 0-2;
  • histological diagnosed diffuse large B cell lymphoma;
  • normal hematological, hepatal, renal function;
  • normal heart function with LVEF ≥ 50%;

Exclusion Criteria:

  • Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions:

    ①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment;

    ②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;

    ③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease.

  • Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening.
  • Congestive heart failure (NYHA) heart function is graded in grade III or IV (Annex 3)
  • Severe arrhythmia requiring treatment.
  • Patients with active hepatitis B and HIV infection.
  • Women who are pregnant or breastfeeding
  • Patients who have received organ transplants in the past
  • Patients with severe active infection
  • Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy

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
NGS Panel
patients who had NGS 481 gene mutation detected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of gene mutation in DLBCL
Time Frame: 3 years
3 years
The incidence of gene mutation in different subtype of DLBCL
Time Frame: 3years
3years
The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Fudan 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)

March 8, 2021

Primary Completion (Anticipated)

February 8, 2022

Study Completion (Anticipated)

February 8, 2024

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gene abnormalities in DLBCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe