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

NCT04957901 | Recruiting

• 1 other identifier: cDNA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• The mutation rate of the ctDNA of pediatric lymphoma

  From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient

Interventions

Pediatric lymphoma protocol DRUG

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Asian population predominates

You may qualify if:

• Children with pediatric lymphoma (HL and NHL) that met the criteria and required treatment upon histological and pathological diagnosis;
• Age: \< 18 years old;
• The working status of the Eastern Cooperative Oncology Group (ECOG) (PS) : 0-2 points;
• 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;
• Complete clinical laboratory examination and pathological examination information;
• Patients can be evaluated on time, and the required samples can be obtained throughout the testing process;
• After the patient is informed of the project, the informed consent signed by the patient or his legal representative is obtained.

You may not qualify if:

• Patients with any of the following items will not be enrolled in this study:
• Incomplete baseline samples (preoperative plasma samples, tissue, bone marrow, cerebrospinal fluid) due to various reasons;
• The follow-up samples cannot be obtained during the monitoring process;
• The researcher considered it unsuitable for enrollment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Yizhuo Zhang

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yizhuo Zhang

  Sun Yat-sen University CancerCenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhuo Zhang

CONTACT

02087342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of pediatric cancer,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 12, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)