Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05778955

Collaborator

Nanjing Geneseeq Technology Inc. (Industry)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Soft Tissue Sarcoma	Genetic: detection and monitoring of cirulating tumor DNA

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University
Nanjing Geneseeq Technology Inc.

Investigators

Principal Investigator: Yizhuo Zhang, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yizhuo Zhang, Director of Pediatric Oncology, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT05778955

Other Study ID Numbers:

ctDNA-P-STS01

First Posted:

Mar 22, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yizhuo Zhang, Director of Pediatric Oncology, Sun Yat-sen University

Pediatric Soft Tissue Sarcoma

ctDNA

NGS

Additional relevant MeSH terms:

Sarcoma

Study Results

No Results Posted as of Mar 22, 2023