Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

Recurrent Childhood Rhabdomyosarcoma Clinical Trial

Official title:

Mechanism of Children With Relapsed and Refractory Rhabdomyosarcoma (RMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040229
• Other study ID #: Children's Oncology Group
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Shandong First Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Childhood Rhabdomyosarcoma
• Embryonal Childhood Rhabdomyosarcoma
• Recurrent Childhood Rhabdomyosarcoma
• Rhabdomyosarcoma

Locations

Country	Name	City	State
China	Jinan central hospital affiliated to Shandong First Medical University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong First Medical University	Shandong Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression pattern	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