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Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

2015年5月17日更新者：Sung Kyu Hong、Seoul National University Hospital

Prospective Cohort Study for the Impact of Preoperative Glycemic Control Status Measured by HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).

The investigators will prospectively collect the relevant data including preoperative HbA1c in 264 patients of PCa patients undergoing RP. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

研究概览

地位

未知

条件

详细说明

This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with prostate cancer (PCa) undergoing radical prostatectomy (RP).
Particularly, the investigators check the variables, including age at surgery, body mass index, comorbidities, preoperative PSA levels, prostate volume measured by TRUS, preoperative HbA1c levels, biopsy Gleason score, positive biopsy cores, percent positive cores, clinical TMN staging, final pathological results (TMN stage, Gleason score, extraprostatic extension, seminal vesicle invasion, surgical margin positivity, postoperative biochemical recurrence (BCR), local recurrence, and distant metastasis during follow-up periods.
The study protocol is same with routine follow-up schedule of the patients with PCa treated with RP. Typically, the investigators check the patients at 1, 3, 6, 9, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

研究类型

观察性的

注册 (预期的)

264

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

大韩民国
- Kyunggi-do
  - Seongnam-si、Kyunggi-do、大韩民国、463-707
    - 招聘中
    - Seoul National University Bundang Hospital
    - 接触：
      
      Sung Kyu Hong, M.D, Ph.D
      
      电话号码：+82-31-787-7343
      
      邮箱：hsk823@chol.com
    - 接触：
      
      Jae-kyung Oh, B.S.
      
      电话号码：+82-31-787-2654
      
      邮箱：r1414@snubh.org

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

非概率样本

研究人群

Enrolled patients should be diagnosed with prostate cancer by TRUS-guided 12 cores biopsy. In addition, the participants should be treated with radical prostatectomy.

描述

Inclusion Criteria:

Prostate cancer diagnosed with prostate biopsy
Clinically localized PCa confirmed by prostate MRI and Bone scan
Patients undergoing RP

Exclusion Criteria:

Distant metastasis, preoperatively
Preoperative hormone therapy
Preoperative chemotherapy
Radiation therapy
Medications affecting glucose status other than diabetes mellitus

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Biochemical recurrence (BCR) 大体时间：postoperative up to 3 years	BCR was defined as either two consecutive increases in serum PSA (>0.2 ng/mL) or the administration of adjuvant therapy during the postoperative follow-up period	postoperative up to 3 years
Pathological Gleason score 大体时间：within 2 weeks after surgery	Gleason scores of prostate cancer specimen described in final pathological report	within 2 weeks after surgery

次要结果测量

结果测量	大体时间
Pathological TMN stage 大体时间：within 2 weeks after surgery	within 2 weeks after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Seoul National University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年5月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2018年6月1日

研究注册日期

首次提交

2015年5月3日

首先提交符合 QC 标准的

2015年5月5日

首次发布 (估计)

2015年5月6日

研究记录更新

最后更新发布 (估计)

2015年5月19日

上次提交的符合 QC 标准的更新

2015年5月17日

最后验证