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

Colorectal Cancer Clinical Trial

— NelyCre  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129046
• Other study ID #: ASO.ChirGen.21.03
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: Igor Monsellato, PhD
• Phone: +390131206078
• Email: igor.monsellato[@]ospedale.al.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2025
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-assisted laparoscopic procedure, all robotic systems will be accepted) or open approach
• Able to give written informed consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Italy	SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease Free Survival	5 years
Secondary	OS	Overall Survival	5 years
Secondary	Surgical Outcomes	Correlation of changes in NLR, PLR and CAR and ILs following complete surgical resection with postoperative complications	90 days