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RecruitingNCT04957901Updated Jun 11, 2025

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

An observational study in Lymphoma, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2021; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

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03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 60 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Asian population predominates

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • DrugPediatric 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.

06

What researchers measure

Primary outcomes

  1. The mutation rate of the ctDNA of pediatric lymphoma

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04957901
Lead sponsor
Sun Yat-sen University
Responsible party
Yizhuo Zhang (Director of department of pediatric cancer,Principal Investigator,Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Jul 12, 2021
Start date
Dec 1, 2021
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Jun 11, 2025

Study contacts

Yizhuo Zhang
Contact
zhangyzh@sysucc.org.cn
02087342460
Yizhuo Zhang
principal investigator · Sun Yat-sen University CancerCenter

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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