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Trial Title:
Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma
NCT ID:
NCT05778955
Condition:
Pediatric Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
Pediatric Soft Tissue Sarcoma
ctDNA
NGS
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
detection and monitoring of cirulating tumor DNA
Description:
detection and monitoring of cirulating tumor DNA in pediatric soft tissue sarcoma
Summary:
Pediatric soft tissue sarcoma is made up of different subtypes, some of which have
distinct genetic alterations. Fusion variants were found in about 43% of bone and soft
tissue sarcoma samples. Ewing sarcoma is characterized by recurrent chromosome
translocation, with up to 95% of cases showing EWS-ETS translocation. The genetic
features of the tumor can change as it spreads or shrinks, and can also be influenced by
treatment.
To better understand treatment response and predict relapse early, our study collects
liquid samples such as blood, bone marrow, or cerebrospinal fluid at various points
during treatment. We then use next-generation sequencing to dynamically monitor the
unique genetic profile of the tumor. Additionally, our research may identify new genetic
targets and suggest potential treatment options.
Criteria for eligibility:
Study pop:
Asian population predominates
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- (1) pediatric patients with soft tissue sarcoma confirmed by pathology(including but
not limited to rhabdomyosarcoma, Ewing sarcoma, BCOR rearrangement undifferentiated
sarcoma, CIC rearrangement undifferentiated sarcoma, Epithelioid sarcoma and
synovial sarcoma.
- (2)younger than 18 years old.
- (3)ECOG status: PS score0-2.
- (4)measurable lesions on CT/MRI according to RECIST 1.1 criteria : long
diameter≥10mm; the longest diameter on ≥ one lymphnode ≥1.5 cm.
- (5)sufficient clinical and pathological information.
- (6)candidates can receive evaluation on time and provide samples during the trials.
- (7)candidates should be informed and provide informed consents.
Exclusion Criteria:
- Sufficient samples at baseline point can not be obtained including pre-operation
plasma, tissues, bone marrow aspirate and cerebrospinal fluid.
- Plasma samples can not be obtained during monitoring.
- Ineligible candidates at the discretion of researchers.
Gender:
All
Minimum age:
6 Months
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi-Zhuo Zhang, MD
Phone:
18622221239
Email:
zhangyzh@sysucc.org.cn
Investigator:
Last name:
Yi-Zhuo Zhang, MD
Email:
Principal Investigator
Start date:
October 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Nanjing Geneseeq Technology Inc.
Agency class:
Industry
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05778955
