Pediatric, Solid Tumors, NGSNCT05076071
Clinical Value of Next Generation Sequencing in Chinese Childhood Solid Tumors
An observational study of Pediatric, Solid Tumors, NGS, run by Yizhuo Zhang at 1 site in China.
Trial summary
Samples of 200 patients with pediatric malignant solid tumors will prospectively be collected. Selected samples are sufficient for next generation sequencing(NGS) and available for follow-up information. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric, Solid Tumors, NGS
- What is being tested?
- NGS
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2021to 6 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 200
Who may be able to join
- Patients are diagnosed by histology and pathology as pediatric malignant solid tumors (including soft tissue sarcoma, osteosarcoma, pediatric glioma, neuroblastoma, nephroblastoma, retinoblastoma, hepatoblastoma, atypical teratoid/rhabdomymoma, embryonal tumor, etc.);
- Age: < 18 years old;
- Eastern Cooperative Oncology Group (ECOG) PS score: 0-2, estimated survival >6 months;
- Complete clinical laboratory examination and pathological examination information of patients;
- Patients can be evaluated on time, and samples can be obtained throughout the whole test process;
- Informed consent signed by the patient or his/her legal representative shall be obtained after the patient is informed of the project;
Who cannot join
- As determined by the investigator, the patient had other major diseases that might affect follow-up and short-term survival;
- Any social/psychological problems that the researcher determines are not suitable for the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yi-Zhuo Zhang, MD, 18622221239, zhangyzh@sysucc.org.cn
Yi-Zhuo Zhang, MD
About this study
Official title: Clinical Value of Next Generation Sequencing in Chinese Childhood Solid Tumors: A Multicenter Study
Samples of 200 patients with pediatric malignant solid tumors will prospectively be collected. Selected samples are sufficient for next generation sequencing(NGS) and available for follow-up information. Multi-omics techniques such as DNA and RNA panel will be used to study driver genes for the development of malignant solid tumors in children, and to explore the pathogenic mechanism. The aim of this study is to explore new biomarkers for the diagnosis and treatment for childhood malignant solid tumors.
Read the detailed description
DNA and RNA extracted from tumor tissues and leukocytes will be analyzed by Onco PanScan/whole exon sequencing(Genetronhealth), and comprehensive gene mutation information such as single nucleotide variation, insertion deletion mutation, gene copy number variants and structure variants will be obtained.
Through in-depth mining of genomic data generated by clinical tumor tissue detection, the differences among different subtypes of pediatric solid tumors in TCGA data will be compared with previous studies. Combined with clinical pathological and molecular subtyping results, auxiliary diagnosis was performed. Analyzing therapeutic targets and identifying pathogenic cancer-predisposing variants may provide molecular reference for children's malignant solid tumors.
- Conditions
- Pediatric, Solid Tumors, NGS
- Being tested
- NGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGSGenetic
Next Generation Sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation characteristics of malignant solid tumors in Chinese children.
Measured: 2021.8-2023.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start6 Aug 2021
- Primary completion6 Jul 2023 (estimated)
- Study completion6 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric, Solid Tumors, NGSStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yizhuo Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076071
- Sponsor's protocol ID
- SunYat-sen U
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu S, Zhang Y, Zhang W, Huang J, Yang C, Wang J, Gao J, Guo X, Yuan X, Chen S, Sun F, Cheng H, Yao W, Dong K, Guo H, Sun X, Li H, Chen K, Lan H, Zhen Z, Zhu J, Zhang X, Que Y, Yan S, Ma J, Li J, Zhu D, Wang H, Wang S, Zhang Y. Precision Medicine Program in Chinese Pediatric Patients With Sarcoma. JCO Precis Oncol. 2026 Jan;10:e2500428. doi: 10.1200/PO-25-00428. Epub 2026 Jan 14.
PubMed 41533994
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Next Generation Sequencing in Chinese Childhood Solid Tumors: A Multicenter Study
- ClinicalTrials.gov ID
- NCT05076071
- Acronym / sponsor ID
- SunYat-sen U
- Conditions
- Pediatric, Solid Tumors, NGS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yizhuo ZhangUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 6 Jul 2023 (estimated)
- Study completion
- 6 Aug 2023 (estimated)
- First posted
- 13 Oct 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.
Samples of 200 patients with pediatric malignant solid tumors will prospectively be collected. Selected samples are sufficient for next generation sequencing(NGS) and available for follow-up information. Multi-omics techniques such as DNA and RNA panel will be used to study driver genes for the development of malignant solid tumors in children, and to explore the pathogenic mechanism. The aim of this study is to explore new biomarkers for the diagnosis and treatment for childhood malignant solid tumors.
Detailed description
DNA and RNA extracted from tumor tissues and leukocytes will be analyzed by Onco PanScan/whole exon sequencing(Genetronhealth), and comprehensive gene mutation information such as single nucleotide variation, insertion deletion mutation, gene copy number variants and structure variants will be obtained.
Through in-depth mining of genomic data generated by clinical tumor tissue detection, the differences among different subtypes of pediatric solid tumors in TCGA data will be compared with previous studies. Combined with clinical pathological and molecular subtyping results, auxiliary diagnosis was performed. Analyzing therapeutic targets and identifying pathogenic cancer-predisposing variants may provide molecular reference for children's malignant solid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 200
Key inclusion criteria (6 listed)
- Patients are diagnosed by histology and pathology as pediatric malignant solid tumors (including soft tissue sarcoma, osteosarcoma, pediatric glioma, neuroblastoma, nephroblastoma, retinoblastoma, hepatoblastoma, atypical teratoid/rhabdomymoma, embryonal tumor, etc.);
- Age: < 18 years old;
- Eastern Cooperative Oncology Group (ECOG) PS score: 0-2, estimated survival >6 months;
- Complete clinical laboratory examination and pathological examination information of patients;
- Patients can be evaluated on time, and samples can be obtained throughout the whole test process;
Key exclusion criteria (2 listed)
- As determined by the investigator, the patient had other major diseases that might affect follow-up and short-term survival;
- Any social/psychological problems that the researcher determines are not suitable for the 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 |
|---|---|---|
| NGSNext Generation Sequencing | Genetic | – |
Primary outcome
Mutation characteristics of malignant solid tumors in Chinese children.
Time frame: 2021.8-2023.8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 41533994Lu S, Zhang Y, Zhang W, Huang J, Yang C, Wang J, Gao J, Guo X, Yuan X, Chen S, Sun F, Cheng H, Yao W, Dong K, Guo H, Sun X, Li H, Chen K, Lan H, Zhen Z, Zhu J, Zhang X, Que Y, Yan S, Ma J, Li J, Zhu D, Wang H, Wang S, Zhang Y. Precision Medicine Program in Chinese Pediatric Patients With Sarcoma. JCO Precis Oncol. 2026 Jan;10:e2500428. doi: 10.1200/PO-25-00428. Epub 2026 Jan 14.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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 Pediatric, Solid Tumors, NGS, run by Yizhuo Zhang 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suying lu (+8613570435681, lusy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutation characteristics of malignant solid tumors in Chinese children. (time frame: 2021.8-2023.8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076071, which also lists 1 linked publication.
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 13 Oct 2021.