跳至主要内容
临床试验/NCT05129046
NCT05129046招募中不适用

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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
DFS

研究概览

简要总结

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.

研究设计

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

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

  • 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

排除标准

  • 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

结局指标

主要结局

DFS

时间窗: 5 years

Disease Free Survival

次要结局

  • OS(5 years)
  • Surgical Outcomes(90 days)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Monsellato

Principal Investigator

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

研究点 (2)

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