Monitoring circulating cell DNA in pediatric non-Hodgkin lymphoma
The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
This study is trying to see if tracking tumor DNA in the blood can help doctors predict how well treatment works and if cancer comes back in kids with non-Hodgkin lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT04957901 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the significance of circulating tumor DNA (ctDNA) in predicting treatment efficacy and recurrence in pediatric patients diagnosed with mature B-cell non-Hodgkin lymphoma (NHL). Utilizing next-generation sequencing, tumor tissue and plasma samples will be collected from patients before, during, and after treatment to analyze genetic mutations. The study follows the modified BFM-95 protocol for treatment and includes a comprehensive assessment of chemotherapy response. By understanding the mutation landscape, the study seeks to improve treatment strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old with newly diagnosed mature B-cell lymphoma requiring treatment.
Not a fit: Patients with incomplete baseline samples or those not meeting the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment outcomes and recurrence in pediatric non-Hodgkin lymphoma patients.
How similar studies have performed: Other studies utilizing ctDNA monitoring in various cancers have shown promising results, indicating potential success for this approach in pediatric NHL.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- Yizhuo Zhang — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Yizhuo Zhang — Sun Yat-sen University CancerCenter
- Study coordinator: Yizhuo Zhang
- Email: zhangyzh@sysucc.org.cn
- Phone: 02087342460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.