Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

NCT06040229 | Completed

• 1 other identifier: Children's Oncology Group
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong First Medical University: lead
• Shandong Tumor Hospital: collaborator

Study Sites (1)

Jinan central hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250017, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

FFPE samples

Study Officials

• Tao Xu

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CN (1)