Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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.

Official Title
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The Significance of Dynamic Monitoring of ctDNA in Pediatric Soft Tissue Sarcoma

Conditions
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Pediatric Soft Tissue Sarcoma

Intervention / Treatment
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* Genetic: detection and monitoring of cirulating tumor DNA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: detection and monitoring of cirulating tumor DNA|detection and monitoring of cirulating tumor DNA in pediatric soft tissue sarcoma|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate to detected tumor progression by ctDNA before radiographic tumor progression | Progression-Free Survival PFS is defined as the time from randomization to progression or death. The definition of ctDNA positive samples : at least one of somatic alterations detected by 475-gene panel. | Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Soft Tissue Sarcoma, ctDNA, NGS