LymphomaNCT04957901
The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
An observational study of Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Pediatric lymphoma protocol
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Asian population predominates
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yizhuo Zhang
Guangzhou
Yizhuo Zhang, 87342460, zhangyzh@sysucc.org.cn
About this 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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- Pediatric lymphoma protocol
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric lymphoma protocolDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The mutation rate of the ctDNA of pediatric lymphoma
Measured: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Dec 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
- Investigators
- Yizhuo Zhang, Principal investigator, Sun Yat-sen University CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957901
- Sponsor's protocol ID
- cDNA
- Status last verified
- Apr 2025
- First submitted
- 5 Jul 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04957901
- Acronym / sponsor ID
- cDNA
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Asian population predominates
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- Patients with any of the following items will not be enrolled in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric lymphoma protocolThe 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. | Drug | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yizhuo Zhang principal investigator
Sun Yat-sen University CancerCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang (02087342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.