The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Mature B Cell Non-Hodgkins Lymphoma (NHL): A Prospective Multicenter Clinical Study

Recruiting

• Conditions: Non-hodgkin Lymphoma

• Registration Number: NCT04957901
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-12
• Study Start: 2021-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Yizhuo Zhang; 🇨🇳 Guangzhou, China