Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03601351
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2018-07-18
Brief Title:
MOR-1 Expression in Colorectal Cancer and Disease-free Survival Relationship Five-year Follow-up
Sponsor:
Hospital Universitario La Fe
Organization:
Hospital Universitario La Fe
Study Overview
Official Title:
Mu Opioid Receptor 1 Expression in Colorectal Cancer and Disease-free Survival Relationship Morocco Five-year Follow-up
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOROCCO
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
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
Detailed Description:
PRIMARY OBJECTIVES
To evaluate the association between Mu opioid receptor 1 MOR-1 expression in patients with colorectal cancer stage II III submitted to scheduled curative surgery and disease-free survival DFS five years follow up after surgery
SECONDARY OBJECTIVES
To evaluate the association between the MOR-1 expression in patients with colorectal cancer stage II III undergoing scheduled curative surgery and overall survival OS five years follow up after surgery
To evaluate the association between MOR-1 expression in patients with colorectal cancer stage II III submitted to scheduled curative surgery and perioperative complications until postoperative day 28th after surgery
To evaluate the association between perioperative opioids dose morphine equivalents and disease-free survivaloverall survival until five years after surgery
To evaluate MOR-1 expression differences in paraffin samples from patients with colorectal cancer stage II III submitted scheduled colorectal surgery between the tumor tissue and the adjacent nontumorous tissue
To evaluate the association between Mu opioid receptor 1 MOR-1 expression in patients with colorectal cancer stage II III submitted to scheduled curative surgery and disease-free survival DFS five years follow up after surgery
SECONDARY OBJECTIVES
To evaluate the association between the MOR-1 expression in patients with colorectal cancer stage II III undergoing scheduled curative surgery and overall survival OS five years follow up after surgery
To evaluate the association between MOR-1 expression in patients with colorectal cancer stage II III submitted to scheduled curative surgery and perioperative complications until postoperative day 28th after surgery
To evaluate the association between perioperative opioids dose morphine equivalents and disease-free survivaloverall survival until five years after surgery
To evaluate MOR-1 expression differences in paraffin samples from patients with colorectal cancer stage II III submitted scheduled colorectal surgery between the tumor tissue and the adjacent nontumorous tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None