NCT01062438

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

February 3, 2010

Last Update Submit

May 5, 2015

Conditions

Sarcoma

Keywords

localized osteosarcomametastatic osteosarcoma

Outcome Measures

Primary Outcomes (4)

  • Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing

  • Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing

  • Mutations associated with outcome

  • Mutations also found in germ line DNA that predispose the patient to osteosarcoma

Interventions

DNA analysisGENETIC
RNA analysisGENETIC
gene expression analysisGENETIC
gene rearrangement analysisGENETIC
mutation analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of localized or metastatic osteosarcoma

DISEASE CHARACTERISTICS: * Diagnosis of localized or metastatic osteosarcoma * Banked snap-frozen tumor tissue samples and paired blood DNA samples available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue

MeSH Terms

Conditions

SarcomaOsteosarcoma

Interventions

Gene Expression ProfilingGene Rearrangement

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesGenetic Phenomena

Study Officials

  • Javed Khan, MD

    NCI - Oncogenomics Section

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 6, 2015

Record last verified: 2015-05