Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer

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.

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing scheduled colorectal surgery for stage II and III primary colorectal cancer during the period 01/01/2010 and 12/31/2014.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with tumor recurrence	Other: Assess the difference in MOR-1 expression between healthy and tumor tissue; 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.
patients with-out tumor recurrence	Other: Assess the difference in MOR-1 expression between healthy and tumor tissue; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Use of halogenated vs intravenous hypnotic agent	Day 1
Carcinoembryonic antigen	Day 1
Cancer antigen	Day 1
Neoadjuvant or adjuvant chemotherapy or radiation therapy	Day 1
Surgery time	Day 1
Surgery date	Day 1
Hospital discharge	Day 1
Surgery complications	Day 1
Type of surgery	Day 1
ASA test	Day 1
Concomitant Diseases	Day 1

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MOROCCO-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No