NCT02417194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

April 6, 2015

Last Update Submit

May 5, 2015

Conditions

Carcinoma, Renal CellPathologyTreatment OutcomeHemoglobin A1c Protein, Human

Keywords

Renal cell carcinomahemoglobin A1c proteinPathologic outcomesOncological outcomesNephrectomy

Outcome Measures

Primary Outcomes (3)

  • TMN stage

    Pathological outcomes

    within 2 weeks after surgery

  • Fuhrman (nuclear) grade

    Pathological outcomes

    within 2 weeks after surgery

  • Recurrence-free survival

    Oncological outcome: recurrence-free survival

    postoperative up to 3 years

Secondary Outcomes (1)

  • Postoperative renal function as assessed by estimated glomerular filtration rate (GFR)

    postoperative up to 3 years

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 15, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

KR(1)