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Observational - Tissue Factor Expression in Bone Sarcomas


N/A
N/A
39 Years
Open (Enrolling)
Both
Localized Osteosarcoma, Metastatic Osteosarcoma, Recurrent Osteosarcoma

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Trial Information

Observational - Tissue Factor Expression in Bone Sarcomas


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Prevalence of high TF expression

Outcome Description:

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.

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Mark Ranalli

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

AOST10B2

NCT ID:

NCT01807052

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Localized Osteosarcoma
  • Metastatic Osteosarcoma
  • Recurrent Osteosarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Children's Oncology GroupArcadia, California  91006-3776