Prognostic Significance of Preoperative Hemoglobin A1c (HbA1c) in Renal Cell Carcinoma

May 5, 2015 updated by: 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 Renal Cell Carcinoma

The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy. The investigators will prospectively collect the relevant data including preoperative HbA1c in 238 patients of RCC patients undergoing nephrectomy. 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.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy.
  • Particularly, the investigators check the variables, including age at surgery, body mass index, sex, comorbidities, preoperative HbA1c levels, blood urea nitrogen (BUN)/creatinine levels, estimated-GFR, clinical TMN staging by CT scan, final pathological results (TMN stage, histology, and Fuhrman nuclear grade), warm ischemic time and surgical margin status (in the case of partial nephrectomy), postoperative recurrence and distant metastasis, renal function changes during follow-up periods.
  • The study protocol is same with routine follow-up schedule of the patients with RCC treated with nephrectomy. Typically, the investigators check the patients at 1, 3, 6, 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.

Study Type

Observational

Enrollment (Anticipated)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyunggi-do
      • Seongnam-si, Kyunggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Sung Kyu Hong, M.D, Ph.D
          • Phone Number: +82-31-787-7343
          • Email: hsk823@chol.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Enrolled patients should be diagnosed with renal cell carcinoma by ultrasonography and/or CT scan, MRI. In addition, the participants should be treated with radical or partial nephrectomy.

Description

Inclusion Criteria:

  • Renal cell carcinoma (RCC) by image work-up such as CT scan
  • Clinically localized RCC
  • Aged over 20 years
  • Patients undergoing radical or partial nephrectomy

Exclusion Criteria:

  • distant metastasis, preoperatively
  • preoperative targeted therapy
  • preoperative immunotherapy
  • medications affecting glucose status other than diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMN stage
Time Frame: within 2 weeks after surgery
Pathological outcomes
within 2 weeks after surgery
Fuhrman (nuclear) grade
Time Frame: within 2 weeks after surgery
Pathological outcomes
within 2 weeks after surgery
Recurrence-free survival
Time Frame: postoperative up to 3 years
Oncological outcome: recurrence-free survival
postoperative up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative renal function as assessed by estimated glomerular filtration rate (GFR)
Time Frame: postoperative up to 3 years
estimated-GFR
postoperative up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-2015-310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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