NCT05076071

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2023

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

September 30, 2021

Last Update Submit

October 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mutation characteristics of malignant solid tumors in Chinese children.

    2021.8-2023.8

Interventions

NGSGENETIC

Next Generation Sequencing

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

200

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
proffesor

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 13, 2021

Study Start

August 6, 2021

Primary Completion

July 6, 2023

Study Completion

August 6, 2023

Last Updated

October 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations