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CompletedNCT01567046Updated May 17, 2016

Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas

An observational study in Childhood Alveolar Soft-part Sarcoma, Childhood Angiosarcoma and Childhood Desmoplastic Small Round Cell Tumor, sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
Up to 30 Years
Sex
All
01

Study summary

This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer

Read the detailed description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Existing NRSTS samples from the COG D9902/ARST0332 studies Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To determine the frequency with which actionable mutations are found in archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor specimens using mass spectrometry (MS) analysis of tumor-derived deoxyribonucleic acid (DNA).

OUTLINE:

Archived DNA tissue samples are analyzed for frequency of genetic mutations, including single nucleotide polymorphisms (SNPs), single nucleotide variants (SNVs), and small deletions and/or insertions, by polymerase chain reaction (PCR) and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.

02

Conditions studied

  • Childhood Alveolar Soft-part Sarcoma
  • Childhood Angiosarcoma
  • Childhood Desmoplastic Small Round Cell Tumor
  • Childhood Epithelioid Sarcoma
  • Childhood Fibrosarcoma
  • Childhood Leiomyosarcoma
  • Childhood Liposarcoma
  • Childhood Malignant Mesenchymoma
  • Childhood Neurofibrosarcoma
  • Childhood Synovial Sarcoma
  • Chordoma
  • Desmoid Tumor
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nonmetastatic Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
03

In context

Hemangiosarcoma

99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.

Browse Hemangiosarcoma studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

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

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-rhabdomyosarcoma soft tissue sarcoma

Eligibility criteria

Inclusion Criteria:

  • Archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor-derived DNA

    • Synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), soft tissue sarcoma not otherwise specified (NOS), or other less common pediatric NRSTS
    • Formalin-fixed, paraffin-embedded (FFPE) tissue from patients enrolled on:

      • COG-D9902 Soft Tissue Sarcoma (STS) Biology and Banking Protocol
      • COG-ARST0332 A Risk-Based Treatment for Pediatric NRSTS Study
  • See Disease Characteristics
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Correlative studies

    Archived DNA tissue samples are analyzed for frequency of genetic mutations, including SNPs, SNVs, and small deletions and/or insertions, by PCR and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.

    Other: laboratory biomarker analysis

Interventions

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Frequency of individual mutated genes in patients with NRSTS

    Time frame: Up to 1 month

  2. Genetic changes that are most common and likely to have the greatest therapeutic impact

    Time frame: Up to 1 month

07

Study locations

1 site
  • Children's Oncology Group
    Monrovia, California 91006-3776, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01567046
Responsible party
Sponsor
First posted
Mar 30, 2012
Start date
May 2016
Primary completion
May 2016
Completion
May 2016
Last update
May 17, 2016

Study contacts

Steve Skapek, MD
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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