Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2010 | ||||
| Last Updated Date | December 22, 2010 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy | ||||
| Official Title ICMJE | Comparison of the Expression Level of Translocator Protein (TSPO) and Binding Activity in Normal Cutaneous Tissue Versus Non Melanotic Cutaneous Malignancy. | ||||
| Brief Summary | 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 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Specimens of normal skin, squamous cell carcinoma or basal cell carcinoma |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Not an observational study. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | July 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01265472 | ||||
| Other Study ID Numbers ICMJE | RMB455-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Rafael Nagler, Rambam Health Care Campus | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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