Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

September 10, 2023 updated by: Shandong First Medical University

Mechanism of Children With Relapsed and Refractory Rhabdomyosarcoma (RMS)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

6

Contacts and Locations

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

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250017
        • Jinan Central Hospital Affiliated to Shandong First Medical University

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants have previously been diagnosed with RMS, a rare and aggressive form of pediatric soft tissue cancer. Importantly, their RMS cases are characterized by recurrence, indicating that the cancer has returned after initial treatment, and refractoriness, meaning it has not responded well to standard therapies.

A defining feature of the study population is the presence of documented lung recurrence. This signifies that the RMS has re-emerged specifically within the lung tissue. Lung recurrence is a critical clinical aspect being investigated in this study.

Description

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.

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
Gene expression pattern
Time Frame: 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.
2023.12.31

Collaborators and Investigators

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

Sponsor

Shandong First Medical University

Collaborators

Shandong Tumor Hospital

Investigators

  • Principal Investigator: Tao Xu, Shandong First Medical University

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)

April 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Children's Oncology Group

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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