Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

March 20, 2023 updated by: Yizhuo Zhang, Sun Yat-sen University

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Yi-Zhuo Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asian population predominates

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Nanjing Geneseeq Technology Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ctDNA-P-STS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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