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OpenTrials
Completed

NCT Number: NCT01062438

Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA analysis

Genetic

RNA analysis

Genetic

gene expression analysis

Genetic

gene rearrangement analysis

Genetic

mutation analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing

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

  3. Mutations associated with outcome

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genomic Study of Metastatic Osteosarcoma Using Next-Generation Sequencing Technology

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2010
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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