An observational study in Colorectal Cancer, sponsored by Hospital Universitario La Fe. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by Hospital Universitario La Fe · Observational
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.
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 survival/overall 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.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's enrollment of 174 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hospital Universitario La Fe is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Patients undergoing scheduled colorectal surgery stage II / III for primary colorectal cancer between 01/01/2010 from 31/12/2013.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Tumor Tissue. Colon or rectum neoplasia stage II and III tumor tissue.
Other: ELISA for MOR-1 expression
Nontumorous Tissue. Colon or rectum neoplasia stage II and III adjacent nontumorous tissue.
Other: ELISA for MOR-1 expression
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.
Expression of MOR1.
Immunohistochemical analysis (ELISA - semiquantitative) to asses expression of MOR1 in tumor tissue and adjacent nontumorous tissue.
Time frame: Six months
Disease free survival.
Disease free survival 5 years after surgery.
Time frame: Five years.
Local recurrence.
Five years follow up after surgery.
Time frame: Five years.
Lymphatic relapse.
Five years follow up after surgery.
Time frame: Five years.
Metastasis.
Reproduction or extension of the tumor to another part of the body. Five years follow up after surgery.
Time frame: Five years.
Type of recurrence (local, regional or distant).
Five years follow up after surgery.
Time frame: Five years.
Overall Survival.
Five years follow up after surgery.
Time frame: Five years.
Morphine equivalents.
Morphine equivalents consumption during perioperative period.
Time frame: During surgery and up to 96 hours during the perioperative period.
Perioperative complications.
Perioperative complications until postoperative day 28th.
Time frame: 28 days.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Fe