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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02417194
• Other study ID #: L-2015-310
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: May 5, 2015
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Hemoglobin A1c Protein, Human
• Pathology
• Treatment Outcome

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMN stage	Pathological outcomes	within 2 weeks after surgery	No
Primary	Fuhrman (nuclear) grade	Pathological outcomes	within 2 weeks after surgery	No
Primary	Recurrence-free survival	Oncological outcome: recurrence-free survival	postoperative up to 3 years	No
Secondary	Postoperative renal function as assessed by estimated glomerular filtration rate (GFR)	estimated-GFR	postoperative up to 3 years	No