NCT01087060

Brief Summary

The aim of this study was to show additional diagnostic criteria of computed tomography (CT) scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship between complicated renal cysts diagnosed by Bosniak system and some parameters of pathological results. The analysis about detection time of renal malignancy would help determine the practical guidelines of follow-up plan for complicated renal cysts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1997

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
Last Updated

March 15, 2010

Status Verified

March 1, 2010

Enrollment Period

11.2 years

First QC Date

March 10, 2010

Last Update Submit

March 12, 2010

Conditions

Kidney NeoplasmCystsCarcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

  • additional diagnostic criteria of CT to diagnose and predict the detection and recurrence of cystic RCC in the patients with complicated renal cysts

    First, the primary outcomes is to determine cut-off values of maximal HU and the maximal gap of HU (HU of early excretory phase minus that of non-enhanced phase in CT scan)to predict the detection of renal malignancy. Some clinical factors (age, height, body weight, etc) were also included in the analysis. Second, the above-mentioned factors were included in the analysis of risk factors for recurrence of complicated renal cysts to determine the cut-off values.

Secondary Outcomes (1)

  • informative to determine the time of operation and which is better for a patient with a complicated cyst between partial or radical nephrectomy

Study Arms (2)

cysts surgically removed

Procedure: partial or radical nephrectomy

cysts under surveillance

Interventions

partial or radical nephrectomyPROCEDURE
cysts surgically removed

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All 2,992 patients who were diagnosed as renal cysts in this institute

You may qualify if:

  • All patients who were diagnosed as renal cysts
  • available serial follow-up data of CT scan
  • all CT imaging included non-enhanced (NEP), corticomedullary (CMP), and early excretory phase (EEP) scans. The scan delay times should range from 30 to 40 seconds for CMP scans and from 120 to 180 seconds for EEP scans.

You may not qualify if:

  • cases diagnosed by only US/MR
  • no serial CT images
  • cysts of autosomal dominant adult polycystic kidney disease
  • cysts less than 1cm in diameter (difficult to evaluate accurately)
  • follow-up period less than 1 yr in the patients who had no surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Song C, Min GE, Song K, Kim JK, Hong B, Kim CS, Ahn H. Differential diagnosis of complex cystic renal mass using multiphase computerized tomography. J Urol. 2009 Jun;181(6):2446-50. doi: 10.1016/j.juro.2009.01.111. Epub 2009 Apr 17.

    PMID: 19375094RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCystsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Cheol Kwak, M.D.,Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 15, 2010

Study Start

January 1, 1997

Primary Completion

March 1, 2008

Study Completion

May 1, 2009

Last Updated

March 15, 2010

Record last verified: 2010-03

Locations

KR(1)