Neutrophil-to-Lymphocite Ratio (NLR) and C-reactive Protein (CRP) as New Markers in Diagnosis and Prediction of Colorectal Cancer

Last updated: April 15, 2024
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Rectal Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT05129046
ASO.ChirGen.21.03
  • Ages > 18
  • All Genders

Study Summary

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the Western world. Overall survival (OS) remains poor, with 50% estimated 5-year survival. In Italy, current estimates indicate that in 2020 a number of 43.700 patients have been affected by colorectal cancer, with an increasing of diagnosed cases in both men and women. It is clear that it is worthwhile to investigate the evaluation of colorectal cancer which could reflect a different spread of screening programs or be the effect of different timing in the start of the programs themselves. To improve the overall survival of colorectal cancer patients, robust biomarkers for screening and predicting disease recurrence could help identify high-risk patients, facilitate a close patient follow-up, and decide appropriate treatment regimens during the postoperative care. Colonoscopy remains the most efficient method for detecting CRC, yet its general application in the setting of screening is limited due to the uncomfortable experience and the high costs. accumulating studies have revealed the potential of systemic inflammatory markers such as C-reactive protein (CRP), albumin, neutrophils, platelets, and lymphocytes, and also biomarker combination ratios [(eg, CRP-albumin ratio (CAR), neutrophil-lymphocyte ratio (NLR), and platelet-lymphocyte ratio (PLR)] as prognostic biomarkers in different cancers, including CRC. Chronic inflammation affects all stages of tumor development. Several studies have shown that various preoperative markers reflecting systemic inflammatory response, including NLR and CRP ratio, offer predictive potential for postoperative morbidity and mortality in CRC patients. However, several issues require addressing prior to the adoption of these inflammatory markers in the clinical practice for CRC patients undergoing surgery: a) the combination of inflammatory factors that might be best in predicting oncological outcomes in colorectal cancer patients remains unclear; b) previous studies for systemic inflammatory markers have mainly interrogated their prognostic potential for oncological outcomes but have not laid emphasis for evaluating their predictive value for postoperative complications; c) there is a lack of consensus on the cut-off thresholds used for each marker for determining mortality risk resulting from surgical and oncological outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • Histologically-proven adenocarcinoma of the colon or the rectum
  • Eligible for a resective surgery by minimally-invasive (standard or robotic-assistedlaparoscopic procedure, all robotic systems will be accepted) or open approach
  • Able to give written informed consent

Exclusion

Exclusion Criteria:

  • Squamous carcinoma of the anal canal
  • History of psychiatric or addictive disorder or other medical condition that, in theopinion of the investigator, would preclude the patient from meeting the trialrequirements
  • Pregnancy
  • Unable to give free informed consent

Study Design

Total Participants: 100
Study Start date:
December 15, 2021
Estimated Completion Date:
November 15, 2025

Connect with a study center

  • SS. Antonio e Biagio e Cesare Arrigo

    Alessandria,
    Italy

    Active - Recruiting

  • IRCCS - Ca' Granda - Fondazione Policlinico di Milano

    Milan,
    Italy

    Site Not Available

  • San Raffaele Hospital

    Milan,
    Italy

    Site Not Available

  • Città della Salute - Chirurgia Generale d'Urgenza e PS

    Turin,
    Italy

    Site Not Available

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