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Biology of Thymic Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965627
First Posted: August 25, 2009
Last Update Posted: August 28, 2009
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.
Information provided by:
Istituto Clinico Humanitas
  Purpose
This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.

Condition
Thymoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Primary objective: to evaluate the presence of genetic alterations and specific potential therapy targets. [ Time Frame: one year ]

Secondary Outcome Measures:
  • Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients. [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
paraffin-embedded tumor specimens of patients

Enrollment: 134
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thymoma and thymic carcinoma patients will be retrospectively analyzed. Patients will be selected based on the availability of tumor tissue.
Criteria

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
  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): NCT00965627


Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00965627     History of Changes
Other Study ID Numbers: ONC/OSS-01/2008
First Submitted: August 6, 2009
First Posted: August 25, 2009
Last Update Posted: August 28, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases