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

Sun Yat-sen University

Status: Enrolling

Conditions: Lymphoma

Treatments: Drug: Pediatric lymphoma protocol

Study type: Observational

Funder types: Other

Identifiers

NCT04957901

cDNA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.