The Significance of Dynamic Monitoring of ctDNA in Pediatric Soft Tissue Sarcoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The rate to detected tumor progression by ctDNA before radiographic tumor progression
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •(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.
Outcomes
Primary Outcomes
The rate to detected tumor progression by ctDNA before radiographic tumor progression
Time Frame: Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients
1. Progression-Free Survival PFS is defined as the time from randomization to progression or death. 2. The definition of ctDNA positive samples : at least one of somatic alterations detected by 475-gene panel.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yizhuo Zhang
Director of Pediatric Oncology
Sun Yat-sen University