Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

NCT05778955 | Unknown

• 1 other identifier: ctDNA-P-STS01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Soft Tissue Sarcoma

Keywords

Pediatric Soft Tissue Sarcoma; ctDNA; NGS

Outcome Measures

Primary Outcomes (1)

• The rate to detected tumor progression by ctDNA before radiographic tumor progression

  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.

  Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients

Interventions

detection and monitoring of cirulating tumor DNA GENETIC

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

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asian population predominates

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Nanjing Geneseeq Technology Inc.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Yizhuo Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Hong

CONTACT

008613760431389; xiaoyu.hong@geneseeq.com

Jia ZHU

CONTACT

008602087342660; zhujia@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Oncology

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 22, 2023
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

CN (1)