MOR-1 Expression in Colorectal Cancer and Disease-free Survival Relationship. Five-year Follow-up.

NCT03601351 | Completed

• 1 other identifier: ODC-MOR-2018-01
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is a global burden and one of the most frequent types of cancer. Colorectal cancer therapy is complex and surgery remains the cornerstone for its treatment, combined with chemotherapy and radiotherapy. At diagnosis time, stage II / III is the predominant . There is a growing interest on the potential effect of perioperative anesthetic management on cancer growth and spread. Preclinical studies suggest that opioids could promote direct tumor growth, angiogenesis, metastasis and immunosuppression of cellular and humoral responses, mainly mediated by Mu opioid receptor 1 (MOR-1) activation. Association between increased expression of MOR-1and or perioperative opioids use and shorter DFS or OS has been demonstrated in lung, prostate, gastric and esophagus cancers. Furthermore a pooled analysis suggested that methylnaltrexone, a peripherally acting Mu-opioid receptor antagonist (PAMORA) was associated with increased survival in patients with advanced cancer. Thus, the expression of the MOR-1 is an indicator of poor prognosis in some cancer types, but its relevance in colon cancer is unknown. The hypothesis of this study is that the increased MOR-1expression in tumor samples from colorectal cancer could be associated to poor disease free survival. These findings would be of great clinical relevance in order to avoid perioperative opioid use in oncological patients. Moreover PAMORAs could be a valuable tool in perioperative antitumor treatment, since currently these drugs are currently used with confirmed tolerability and low adverse effects in the management of opioid-induced constipation (Opioid Induced Constipation-OIC). Besides MOR 1 expression could constitute a biomarker that guide the investigators to perform neoadjuvant therapy.

Conditions

Colorectal Cancer

Keywords

CANCER, COLON, OPIOIDS, MOR-1

Outcome Measures

Primary Outcomes (2)

• Expression of MOR1.

  Immunohistochemical analysis (ELISA - semiquantitative) to asses expression of MOR1 in tumor tissue and adjacent nontumorous tissue.

  Six months

• Disease free survival.

  Disease free survival 5 years after surgery.

  Five years.

Secondary Outcomes (7)

• Local recurrence.

  Five years.

• Lymphatic relapse.

  Five years.

• Metastasis.

  Five years.

• Type of recurrence (local, regional or distant).

  Five years.

• Overall Survival.

  Five years.

Study Arms (2)

TT

Tumor Tissue. Colon or rectum neoplasia stage II and III tumor tissue.

Other: ELISA for MOR-1 expression

NTT

Nontumorous Tissue. Colon or rectum neoplasia stage II and III adjacent nontumorous tissue.

Other: ELISA for MOR-1 expression

Interventions

ELISA for MOR-1 expression OTHER

To evaluate MOR-1 expression differences by immunohistochemical analysis (ELISA - semiquantitative) in paraffin samples from patients with colorectal cancer stage II / III submitted scheduled colorectal surgery between the tumor tissue and the adjacent nontumorous tissue.

NTT; TT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing scheduled colorectal surgery stage II / III for primary colorectal cancer between 01/01/2010 from 31/12/2013.

You may qualify if:

• Patients older than 18 years.
• Colorectal scheduled surgery between January 2010- December 2013.
• Colon / rectum neoplasia Stage II / III (T3 / T4 N + M0).

You may not qualify if:

• Stage I or Stage IV
• Non-oncological colorectal surgery
• Non-elective surgery

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• OSCAR DIAZ-CAMBRONERO, MD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 26, 2018
• Study Start: May 4, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

ES (1)