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

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ClinicalTrials.gov Identifier: NCT03601351
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Oscar Diaz-Cambronero, Hospital Universitario La Fe

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.


Condition or disease Intervention/treatment
Colorectal Cancer Other: ELISA for MOR-1 expression

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 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.


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Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mu Opioid Receptor 1 Expression in Colorectal Cancer and Disease-free Survival Relationship (Morocco). Five-year Follow-up.
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TT
Tumor Tissue. Colon or rectum neoplasia stage II and III tumor 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.

NTT
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.




Primary Outcome Measures :
  1. Expression of MOR1. [ Time Frame: Six months ]
    Immunohistochemical analysis (ELISA - semiquantitative) to asses expression of MOR1 in tumor tissue and adjacent nontumorous tissue.

  2. Disease free survival. [ Time Frame: Five years. ]
    Disease free survival 5 years after surgery.


Secondary Outcome Measures :
  1. Local recurrence. [ Time Frame: Five years. ]
    Five years follow up after surgery.

  2. Lymphatic relapse. [ Time Frame: Five years. ]
    Five years follow up after surgery.

  3. Metastasis. [ Time Frame: Five years. ]
    Reproduction or extension of the tumor to another part of the body. Five years follow up after surgery.

  4. Type of recurrence (local, regional or distant). [ Time Frame: Five years. ]
    Five years follow up after surgery.

  5. Overall Survival. [ Time Frame: Five years. ]
    Five years follow up after surgery.

  6. Morphine equivalents. [ Time Frame: During surgery and up to 96 hours during the perioperative period. ]
    Morphine equivalents consumption during perioperative period.

  7. Perioperative complications. [ Time Frame: 28 days. ]
    Perioperative complications until postoperative day 28th.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601351


Locations
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Spain
Hospital Universitario La Fe
Valencia, Spain
Sponsors and Collaborators
Hospital Universitario La Fe
Investigators
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Principal Investigator: OSCAR DIAZ-CAMBRONERO, MD Hospital Universitario La Fe

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Responsible Party: Oscar Diaz-Cambronero, PRINCIPAL INVESTIGATOR, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT03601351     History of Changes
Other Study ID Numbers: ODC-MOR-2018-01
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oscar Diaz-Cambronero, Hospital Universitario La Fe:
CANCER, COLON, OPIOIDS, MOR-1
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases