Trial record 2 of 101 for:    Open Studies | "Osteosarcoma"

Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01807052
First received: March 6, 2013
Last updated: August 5, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 34
Study Start Date: November 2009
Estimated Primary Completion Date: January 2100 (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

Ages Eligible for Study:   up to 39 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807052

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Mark A. Ranalli    614-722-3563    mark.ranalli@nationwidechildrens.org   
Principal Investigator: Mark A. Ranalli         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Mark Ranalli Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01807052     History of Changes
Other Study ID Numbers: AOST10B2, NCI-2013-00112, COG-AOST10B2
Study First Received: March 6, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014