NCT04957901 The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
| NCT ID | NCT04957901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yizhuo Zhang
PRINCIPAL INVESTIGATOR
Sun Yat-sen University CancerCenter
Frequently Asked Questions
Who can join the NCT04957901 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04957901 currently recruiting?
Yes, NCT04957901 is actively recruiting participants. Contact the research team at zhangyzh@sysucc.org.cn for enrollment information.
Where is the NCT04957901 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04957901 clinical trial?
NCT04957901 is sponsored by Sun Yat-sen University. The principal investigator is Yizhuo Zhang at Sun Yat-sen University CancerCenter. The trial plans to enroll 60 participants.