Clinical trial NCT01567046: Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas
Official title: Observational - Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-30
Enrollment: 70
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-rhabdomyosarcoma soft tissue sarcoma

Brief 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

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.

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

Primary outcomes:
measure: Frequency of individual mutated genes in patients with NRSTS
timeFrame: Up to 1 month
measure: Genetic changes that are most common and likely to have the greatest therapeutic impact
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Steve Skapek, MD
role: PRINCIPAL_INVESTIGATOR
References: