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Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

Sponsor
Shandong First Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06040229
Collaborator
Shandong Tumor Hospital (Other)
6
Enrollment
1
Location
5
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This retrospective study is looking into mechanisms of drug therapy resistance in FFPE samples in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients who have experienced lung recurrence. The study employs advanced techniques such as single-cell transcriptomics and spatial transcriptomics to gain a comprehensive understanding of these mechanisms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This research seeks to enhance our understanding of drug resistance mechanisms in recurrent and refractory RMS in pediatric patients, particularly in the context of lung recurrence. The utilization of cutting-edge techniques like single-cell transcriptomics and spatial transcriptomics allows for a more in-depth and comprehensive analysis of the molecular and spatial aspects of drug resistance in this challenging pediatric cancer.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Mechanism of Children With Relapsed and Refractory Rhabdomyosarcoma (RMS)
    Actual Study Start Date :
    Apr 1, 2023
    Actual Primary Completion Date :
    Jul 1, 2023
    Actual Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Gene expression pattern [2023.12.31]

      Identification and characterization of specific genetic alterations and gene expression patterns associated with drug therapy resistance in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients, particularly in cases of lung recurrence, using single-cell transcriptomics and spatial transcriptomics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Pediatric Patients: Participants in this study should be pediatric patients, typically defined as individuals aged from infancy to 18 years old, who have been diagnosed with recurrent and refractory Rhabdomyosarcoma (RMS).

    2. Lung Recurrence: Included patients must have a documented history of lung recurrence of RMS as a specific clinical manifestation.

    3. Availability of FFPE Samples: Patients for whom formalin-fixed paraffin-embedded (FFPE) tissue samples are available for analysis are eligible for inclusion.

    Exclusion Criteria:

    1. Other Histological Types: Patients with RMS of histological subtypes other than those relevant to the study focus are excluded.

    2. Incomplete Clinical Data: Patients with incomplete or insufficient clinical data necessary for the study's objectives may be excluded to ensure robust analysis and interpretation of results.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinan central hospital affiliated to Shandong First Medical University Jinan Shandong China 250017

    Sponsors and Collaborators

    • Shandong First Medical University
    • Shandong Tumor Hospital

    Investigators

    • Principal Investigator: Tao Xu, Shandong First Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shandong First Medical University
    ClinicalTrials.gov Identifier:
    NCT06040229
    Other Study ID Numbers:
    • Children's Oncology Group
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 15, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rhabdomyosarcoma
    Rhabdomyosarcoma, Embryonal

    Study Results

    No Results Posted as of Sep 15, 2023