The effect of neoadjuvant treatment of colorectal cancer with simvastatin on the expression and activation of elements of the Bone Morphogenetic Protein pathway.
Completed
- Conditions
- colon cancercolorectal adenocarcinoma10017990
- Registration Number
- NL-OMON31290
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
>18 years
histologically confirmed colorectal cancer
Eligible for surgical resection
Exclusion Criteria
Current use of cholesterol lowering drugs or NSAIDs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A tissue microarray (TMA) will be used to semi-quantify the protein expression<br /><br>levels in the resection specimens of treated and nontreated patients. The TMA<br /><br>will be analysed by immunohistochemistry for levels of BMP2 and 4, pSMAD1,<br /><br>SMAD4 and ID-2. We will also analyse markers of apoptosis (cleaved caspase 3)<br /><br>proliferation (Ki-67) and angiogenesis (VEGF and CD31). Staining will be scored<br /><br>in a semiquantitative fashion by 3 independent investigators with no patient<br /><br>information.<br /><br>Tumour samples taken before initiation of Simvastatin treatment will be<br /><br>compared to tumour samples taken after therapy. We will use<br /><br>immunohistochemistry for elements of the BMP pathway as well as Elisa (BMP2)<br /><br>and qRT-PCR using the frozen tissue where RNA and protein will be isolated from<br /><br>samples that consist of more that 70% tumour cells as analysed by frozen<br /><br>section. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>