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临床试验/NCT04857203
NCT04857203Unknown不适用

The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
The Role of Vitamin D in response to neoadjuvant therapy for the patients with locally advanced rectal cancer

研究概览

简要总结

It has been reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. In addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. Therefore, the importance of predicting patients with pathological complete response has increased.

It has been reported that data obtained from PET-CT scans and clinical information such as tumor size, T stage, and N stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer.

Consideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. Because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. There are a limited number of blood biomarkers such as CEA and IL-6 that have been studied in the literature.

Experimental studies show that vitamin D suppresses inflammation and protects against cancer by triggering differentiation. In 1980, Cedric and Frank Garland stated for the first time that vitamin D may affect the survival of the patient after the diagnosis of colorectal cancer. In later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin D - 25 (OH) D and survival rates for colorectal cancer, breast and prostate cancer. In addition, 25 (OH) D serum concentration has been shown to be inversely related to colorectal cancer progression.

In the light of all these information, the role of serum vitamin D levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• All patients with locally advanced rectal cancer

排除标准

  • •• below 18 years old
  • •patients who did not received neoadjuvant therapy

结局指标

主要结局

The Role of Vitamin D in response to neoadjuvant therapy for the patients with locally advanced rectal cancer

时间窗: 8 weeks

The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer Vitamin D levels will be measured for all the patients just before the neoadjuvant therapy.

次要结局

未报告次要终点

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Cihad Tatar

Associate Professor

Istanbul Training and Research Hospital

研究点 (1)

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