Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma

NCT ID: NCT05778955

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Soft Tissue Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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detection and monitoring of cirulating tumor DNA

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

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Geneseeq Technology Inc.

INDUSTRY

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yizhuo Zhang

Director of Pediatric Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yizhuo Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyu Hong

Role: CONTACT

008613760431389

Jia ZHU

Role: CONTACT

008602087342660

Facility Contacts

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Yi-Zhuo Zhang, MD

Role: primary

18622221239

Other Identifiers

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ctDNA-P-STS01

Identifier Type: -

Identifier Source: org_study_id

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