NCT05042089

Brief Summary

The investigators aimed to evaluate the role of some findings that can be detected in preoperative radiological imaging of kidney masses in predicting locally advanced disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 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

May 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

September 4, 2021

Last Update Submit

September 16, 2021

Conditions

Keywords

Renal Cell CarcinomaTomographyMagnetic resonance imaging

Outcome Measures

Primary Outcomes (3)

  • Renal capsule invasion

    Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) renal capsule invasion.

    1 month

  • Perirenal fat tissue invasion

    Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) perirenal fat tissue invasion

    1 month

  • Thickening of the Gerota's fascia

    Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) thickening of the Gerota's fascia.

    1 month

Study Arms (2)

pathological tumor stage 1-2 (pT1-2)

Stage pT1 and pT2 according to pathology results of patients who underwent partial or radical nephrectomy.

Other: No intervention will be applied.

pathological tumor stage ≥pT3a

Stage ≥pT3a according to pathology results of patients who underwent partial or radical nephrectomy.

Other: No intervention will be applied.

Interventions

The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined.

pathological tumor stage 1-2 (pT1-2)pathological tumor stage ≥pT3a

Eligibility Criteria

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

Patients aged 20-80 years who have a renal mass detected by CT or MR imaging in the urology outpatient clinic and undergo partial or radical nephrectomy.

You may qualify if:

  • patients operated for kidney mass
  • patients with preoperative CT or MRI imaging

You may not qualify if:

  • metastatic RCC
  • who had undergone surgery on the same side before kidney mass due to other urological pathologies
  • who had pathology results other than RCC (oncocytoma, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University, Schhol of Medicine

Ankara, 06800, Turkey (Türkiye)

Location

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 Officials

  • Selman Unal

    Ankara Yildirim Beyazit University School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 13, 2021

Study Start

May 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations