NCT01265472

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 23, 2010

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

December 22, 2010

Last Update Submit

December 22, 2010

Conditions

Keywords

Translocator ProteinBasal Cell CarcinomaSquamous Cell CarcinomaMalignancy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Not an observational study.

You may qualify if:

  • Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens of normal skin, squamous cell carcinoma or basal cell carcinoma

MeSH Terms

Conditions

Carcinoma, Squamous CellCarcinoma, Basal CellNeoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellNeoplasms, Basal Cell

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 23, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

December 23, 2010

Record last verified: 2010-12