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Biology of Thymic Tumors

This study has been completed.
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00965627
First received: August 6, 2009
Last updated: August 27, 2009
Last verified: August 2009
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients. [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00965627     History of Changes
Other Study ID Numbers: ONC/OSS-01/2008
Study First Received: August 6, 2009
Last Updated: August 27, 2009
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 22, 2013