Biology of Thymic Tumors

Thymoma Clinical Trial

Official title:

Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965627
• Other study ID #: ONC/OSS-01/2008
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: August 27, 2009
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.

Description:

The aim of the present study is to investigated the genetic alterations in tumor samples of a series of all WHO-defined subtypes of thymoma patients using high resolution microarray- comparative genomic hybridization (CGH) followed by hierarchical cluster analyses of the data to identify specific patterns of genetic aberrations and genes associated with each subtype. Moreover, tumor samples will be also investigated for some specific potential therapy targets by immunoistichemistry, mutation analysis, and fluorescence in situ hybridization (FISH) analysis. All these biological data will be correlated with clinical patients characteristics and survival data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Availability of tumor tissue and patients with thymoma and thymic carcinoma

Exclusion Criteria:

• NON Availability of tumor tissue and patients with thymoma and thymic carcinoma

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thymoma

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective: to evaluate the presence of genetic alterations and specific potential therapy targets.		one year	No
Secondary	Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients.		one year	No