Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04957901
Enrollment
60
Registered
2021-07-12
Start date
2021-12-01
Completion date
2026-06-01
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

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.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The mutation rate of the ctDNA of pediatric lymphomaFrom the beginning of observation to the end of observation(6 weeks) of the last enrolled patient

Countries

China

Contacts

Primary ContactYizhuo Zhang
zhangyzh@sysucc.org.cn02087342460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026