Clinical trial NCT04957901: The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
Official title: The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asian population predominates

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mutation rate of the ctDNA of pediatric lymphoma
timeFrame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yizhuo Zhang
Study officials:
affiliation: Sun Yat-sen University CancerCenter
name: Yizhuo Zhang
role: PRINCIPAL_INVESTIGATOR
References: