NCT01567046

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
4.1 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

March 27, 2012

Last Update Submit

May 13, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Frequency of individual mutated genes in patients with NRSTS

    Up to 1 month

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

    Up to 1 month

Study Arms (1)

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

Correlative studies

Correlative studies

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Non-rhabdomyosarcoma soft tissue sarcoma

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

HemangiosarcomaDesmoplastic Small Round Cell TumorSarcomaFibrosarcomaLiposarcomaMalignant mesenchymal tumorChordomaDesmoid Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Adipose TissueNeoplasms, Germ Cell and EmbryonalFibroma

Study Officials

  • Steve Skapek, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 30, 2012

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations