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NCT Number: NCT04957901

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

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.

Recruiting

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yizhuo Zhang

CONTACT

[email protected]

02087342460

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2021
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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