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Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01807052
First Posted: March 8, 2013
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

Condition Intervention
Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational - Tissue Factor Expression in Bone Sarcomas

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Prevalence of high TF expression [ Time Frame: 1 month ]
    Estimated in the analytic population as the number of samples in the population in which such expression is noted divided by 33. An assessment of the precision of such estimates will be provided by an exact binomial confidence interval. Comparison of normalized TF expression in non-metastatic versus metastatic patients will be done using the two-sample t-test.


Enrollment: 34
Study Start Date: November 2009
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

STUDY SUBTYPE: Ancillary/Correlative

OBSERVATIONAL STUDY MODEL: Case-only

TIME PERSPECTIVE: Retrospective

BIOSPECIMEN RETENTION: Samples without DNA

BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN)

STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials

SAMPLING METHOD: Non-probability sample

PRIMARY OBJECTIVES:

I. To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma.

II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression.

III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases.

OUTLINE:

Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tissue samples from patients with osteosarcomas obtained from the CHTN that participated in either study P9754 clinical trial for patients with non-metastatic osteosarcoma or AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
Criteria

Inclusion Criteria:

  • Tissue samples from patients with osteosarcomas obtained from the CHTN:

    • P9754 clinical trial for patients with non-metastatic osteosarcoma
    • AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807052


Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Ranalli, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01807052     History of Changes
Other Study ID Numbers: AOST10B2
NCI-2013-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AOST10B2 ( Other Identifier: Children's Oncology Group )
First Submitted: March 6, 2013
First Posted: March 8, 2013
Last Update Posted: May 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue