跳至主要内容
临床试验/NCT03601351
NCT03601351已完成不适用

Mu Opioid Receptor 1 Expression in Colorectal Cancer and Disease-free Survival Relationship (Morocco). Five-year Follow-up.

Hospital Universitario La Fe1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2018年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Expression of MOR1.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Expression of MOR1.

时间窗: Six months

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

Disease free survival.

时间窗: Five years.

Disease free survival 5 years after surgery.

次要结局

  • Lymphatic relapse.(Five years.)
  • Type of recurrence (local, regional or distant).(Five years.)
  • Overall Survival.(Five years.)
  • Local recurrence.(Five years.)
  • Metastasis.(Five years.)
  • Morphine equivalents.(During surgery and up to 96 hours during the perioperative period.)
  • Perioperative complications.(28 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Diaz-Cambronero

PRINCIPAL INVESTIGATOR

Hospital Universitario La Fe

研究点 (1)

Loading locations...

相似试验