Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy

December 22, 2010 updated by: Rambam Health Care Campus

Comparison of the Expression Level of Translocator Protein (TSPO) and Binding Activity in Normal Cutaneous Tissue Versus Non Melanotic Cutaneous Malignancy.

Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO expression in the skin correlates with cell proliferation and differentiation. Many studies have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon cancer, and others, was also found to correlate with more aggressive cancer behavior. Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in solid malignancies as compared to normal tissues. It is assumed that this aberration can be found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in malignancies in general. Methods: The study will be carried out on surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of the surgical routine treatment. The excision will be made in elliptic shape including the lesion and a part of normal skin surrounding it. A sample will be taken from the central part of the lesion and from the external extremity of the normal tissue. Western Blot will be conducted to detect the expression of TSPO. Binding activity with the TSPO specific ligandwill also be determined. Expected Results: We expect to observe either (a) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue. Importance: Until today, only a very small number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO expression. Our study will also measure the binding activity of TSPO in cutaneous malignant tissues compared to normal tissues

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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Participation Criteria

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Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Not an observational study.

Description

Inclusion Criteria:

  • Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Exclusion Criteria:

  • Non-compliance with inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2010

Last Update Submitted That Met QC Criteria

December 22, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

  • RMB455-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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