The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study

NCT ID: NCT04957901

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-06-01

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 lymphoma 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 lymphoma.

Detailed Description

This is a prospective, multi-center, observational cohort study. 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 lymphoma and to evaluate the significance of liquid biopsy for efficacy prediction, predicting recurrence, mechanism of resistance to chemotherapy.

Conditions

Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Pediatric lymphoma 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Children with pediatric lymphoma (HL and NHL) 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yizhuo Zhang

Director of department of pediatric cancer,Principal Investigator,Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhuo Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University CancerCenter

Locations

Yizhuo Zhang

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yizhuo Zhang

Role: CONTACT

zhangyzh@sysucc.org.cn

02087342460

Facility Contacts

Yizhuo Zhang

Role: primary

zhangyzh@sysucc.org.cn

87342460

Other Identifiers

cDNA

Identifier Type: -

Identifier Source: org_study_id