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Biology of Thymic Tumors

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ClinicalTrials.gov Identifier: NCT00965627
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
Istituto Clinico Humanitas

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

Condition or disease
Thymoma

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.

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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


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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

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

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 Posted: August 25, 2009    Key Record Dates
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