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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02417194
Collaborator
(none)
238
Enrollment
1
Location
36
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    238 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Apr 1, 2015
    Anticipated Primary Completion Date :
    Apr 1, 2018
    Anticipated Study Completion Date :
    Apr 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. TMN stage [within 2 weeks after surgery]

      Pathological outcomes

    2. Fuhrman (nuclear) grade [within 2 weeks after surgery]

      Pathological outcomes

    3. Recurrence-free survival [postoperative up to 3 years]

      Oncological outcome: recurrence-free survival

    Secondary Outcome Measures

    1. Postoperative renal function as assessed by estimated glomerular filtration rate (GFR) [postoperative up to 3 years]

      estimated-GFR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Kyunggi-do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sung Kyu Hong, Associate professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT02417194
    Other Study ID Numbers:
    • L-2015-310
    First Posted:
    Apr 15, 2015
    Last Update Posted:
    May 7, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Sung Kyu Hong, Associate professor, Seoul National University Bundang Hospital
    Renal cell carcinoma
    hemoglobin A1c protein
    Pathologic outcomes
    Oncological outcomes
    Nephrectomy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of May 7, 2015