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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062438
Other study ID # AOST10B3
Secondary ID COG-AOST10B3CDR0
Status Completed
Phase N/A
First received February 3, 2010
Last updated May 5, 2015
Start date January 2010
Est. completion date September 2011

Study information

Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


Description:

OBJECTIVES:

- Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.

- Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.

- Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.

- Identify which mutations are associated with outcome.

- Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.

OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.

Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Genetic:
DNA analysis

RNA analysis

gene expression analysis

gene rearrangement analysis

mutation analysis

Other:
laboratory biomarker analysis


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing No
Primary Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing No
Primary Mutations associated with outcome No
Primary Mutations also found in germ line DNA that predispose the patient to osteosarcoma No
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