Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer

• Conditions: Colorectal Surgery for Stage II / III Primary Colorectal Cancer
• Interventions: Other: Assess the difference in MOR-1 expression between healthy and tumor tissue

• Registration Number: NCT04353882
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19
• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with tumor recurrence	Assess the difference in MOR-1 expression between healthy and tumor tissue	-
patients with-out tumor recurrence	Assess the difference in MOR-1 expression between healthy and tumor tissue	-

Primary Outcome Measures

Name	Time	Method
MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue.	Day 1

Secondary Outcome Measures

Name	Time	Method
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