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CompletedNCT06040229Updated Sep 15, 2023

Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

An observational study in Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma and Recurrent Childhood Rhabdomyosarcoma, sponsored by Shandong First Medical University. Completed at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by Shandong First Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6
Ages
1 Year to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alveolar Childhood Rhabdomyosarcoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma
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In context

Rhabdomyosarcoma

238 studies on the registry are indexed under Rhabdomyosarcoma; 47 are open to participants now.

This study's enrollment of 6 is below the median of 99 across 31 observational studies indexed under Rhabdomyosarcoma.

Browse Rhabdomyosarcoma studies →

Lead sponsor

Shandong First Medical University is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

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.

    Time frame: 2023.12.31

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Study locations

1 site
  • Jinan central hospital affiliated to Shandong First Medical University
    Jinan, Shandong 250017, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06040229
Lead sponsor
Shandong First Medical University
Collaborators
Shandong Tumor Hospital
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Apr 1, 2023
Primary completion
Jul 1, 2023
Completion
Sep 1, 2023
Last update
Sep 15, 2023

Study contacts

Tao Xu
principal investigator · Shandong First Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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