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

NCT ID: NCT05129046

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

OTHER

Sponsor Role lead

Responsible Party

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Igor Monsellato

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SS. Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status RECRUITING

San Raffaele Hospital

Milan, , Italy

Site Status ENROLLING_BY_INVITATION

Countries

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Italy

Central Contacts

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Igor Monsellato, PhD

Role: CONTACT

+390131206078

Carolina Pelazza

Role: CONTACT

+390131206893

Facility Contacts

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Igor Monsellato, PhD

Role: primary

+390131206078

Other Identifiers

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ASO.ChirGen.21.03

Identifier Type: -

Identifier Source: org_study_id

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