Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer

Study Overview
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Brief Summary
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Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery.

Detailed Description
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Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Period January 2010-December 2014. Patients must have had at least 5 years of follow-up to define disease-free survival. From the cohort of patients previously studied in our center by immunohistochemistry, 31 we will select 10 cases with recurrence by random sampling and we will match 10 controls by leveling the propensity score (propensity score matching).

Official Title
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Evaluation of the Difference in Expression of the Mu Type 1 Opioid Receptor and of the Markers of Its Activation (Cyclic Adenosine Monophosphate and Protein Kinase A) in Colorectal Cancer. Case-control Study in Patients With Tumor Recurrence Versus Disease-free Patients at 5 Years.

Conditions
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Colorectal Surgery for Stage II / III Primary Colorectal Cancer

Intervention / Treatment
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* Other: Assess the difference in MOR-1 expression between healthy and tumor tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age. Colorectal surgery scheduled between January 2010 - December 2014. Stage II or III colon or rectum neoplasm (T3 / T4 N + M0). Exclusion Criteria: Neoplasia of colon or rectum in Stage I or Stage IV. Non-oncological colorectal surgery. Urgent surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with tumor recurrence<br> | Other: Assess the difference in MOR-1 expression between healthy and tumor tissue<br>* Assess the difference in the quantitative expression of MOR-1 (by means of RT-qPCR) between healthy tissue and tumor tissue, in patients with stage II and III colorectal cancer undergoing scheduled surgery.<br>|
| patients with-out tumor recurrence<br> | Other: Assess the difference in MOR-1 expression between healthy and tumor tissue<br>* Assess the difference in the quantitative expression of MOR-1 (by means of RT-qPCR) between healthy tissue and tumor tissue, in patients with stage II and III colorectal cancer undergoing scheduled surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue. |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-free survival 5 years after surgery (disease-free survival-DFS). |  | Day 1 | 
| Degree of MOR-1 activation measured by immunohistochemistry through cAMP and PKA levels. |  | Day 1 | 
| MOR-1 expression by immunohistochemistry in tumor tissue and adjacent healthy tissue. |  | Day 1 |