The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Mature B Cell Non-Hodgkins Lymphoma (NHL).

September 19, 2023 updated by: Yizhuo Zhang, Sun Yat-sen University
The next-generation sequencing (NGS) based on liquid biopsy has been an emerging technology to identify tumor-specific genetic aberrations in malignant tumors. The tumor tissue (FFPE) and plasma samples from the newly diagnosed pediatric mature B-NHL patients were collected and sequenced by 475 genes panel before, during and post treatment, to evaluate the significance of the ctDNA in efficacy prediction, predicting recurrence or mechanism of resistance to chemotherapy for pediatric mature B-NHL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, observational cohort study. Clinical stage system, risk stratification and treatment for pediatric mature B-NHL were according to the modified BFM-95 protocol. The tumor tissue (FFPE) and plasma samples (bone marrow or cerebrospinal fluid samples if necessary) from the newly diagnosed patients were collected and sequenced by 475 genes panel before, during and post treatment. Collection and analysis the results of ctDNA and chemotherapy response, to explore the mutation map of pediatric mature B-NHL and to evaluate the significance of liquid biopsy for efficacy prediction, predicting recurrence, mechanism of resistance to chemotherapy.

Study Type

Observational

Enrollment (Estimated)

60

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

Study Locations

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Asian population predominates

Description

Inclusion Criteria:

  1. Children with mature B-cell lymphoma (BL, DLBCL, high-grade B-cell lymphoma, mediastinal large B-cell lymphoma) that met the criteria and required treatment upon histological and pathological diagnosis;
  2. Age: < 18 years old;
  3. The working status of the Eastern Cooperative Oncology Group (ECOG) (PS) : 0-2 points;
  4. CT/MRI measurable lesion was defined as the longest diameter of at least 1 lymph node ≥ 1.5cm, and it was clearly measurable in 2 vertical directions;
  5. Complete clinical laboratory examination and pathological examination information;
  6. Patients can be evaluated on time, and the required samples can be obtained throughout the testing process;
  7. After the patient is informed of the project, the informed consent signed by the patient or his legal representative is obtained.

Exclusion Criteria:

  • Patients with any of the following items will not be enrolled in this study:

    1. Incomplete baseline samples (preoperative plasma samples, tissue, bone marrow, cerebrospinal fluid) due to various reasons;
    2. The follow-up samples cannot be obtained during the monitoring process;
    3. The researcher considered it unsuitable for enrollment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mutation rate of the ctDNA of pediatric mature B-NHL
Time Frame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhuo Zhang, Sun Yat-sen University CancerCenter

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)

December 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cDNA

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.

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