Skip to content

Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05778955
Enrollment
40
Registered
2023-03-22
Start date
2022-10-01
Completion date
2023-12-31
Last updated
2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Soft Tissue Sarcoma

Keywords

Pediatric Soft Tissue Sarcoma, ctDNA, NGS

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.

Interventions

GENETICdetection and monitoring of cirulating tumor DNA

detection and monitoring of cirulating tumor DNA in pediatric soft tissue sarcoma

Sponsors

Nanjing Geneseeq Technology Inc.
CollaboratorINDUSTRY
Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
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 score0-2. * (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.

Design outcomes

Primary

MeasureTime frameDescription
The rate to detected tumor progression by ctDNA before radiographic tumor progressionOct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients1. 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.

Countries

China

Contacts

Primary ContactXiaoyu Hong
xiaoyu.hong@geneseeq.com008613760431389
Backup ContactJia ZHU
zhujia@sysucc.org.cn008602087342660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026