Renal Malignant TumorNCT05042089
Predictive Imaging Features in Renal Cell Carcinoma
An observational study of Renal Malignant Tumor, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Renal Malignant Tumor
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients operated for kidney mass
- patients with preoperative CT or MRI imaging
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University, Schhol of Medicine
Ankara, 06800
About this study
Official title: Predictive Features of Pre-operative Computed Tomography and Magnetic Resonance Imaging for Advanced Disease in Renal Cell Carcinoma
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.
Read the detailed description
Renal cell carcinoma (RCC) is one of the most common urinary system cancers and accounts for 3% of all cancers. With the frequent use of imaging methods most renal masses are detected localized. The standard treatment option in localized RCC is radical nephrectomy (RN) or nephron-sparing surgery (NSS). NSS is preferred when appropriate in patients with tumor stage 1 (T1) and has been shown to be comparable to RN in terms of oncologic outcomes. Although there is no prospective randomized study comparing NSS with RN in terms of oncological and renal functions in T2 patients, there are retrospective studies conducted to date. According to the current European urology guideline, the standard approach in patients with T2 and above is RN. Pre-operative clinical staging is performed with computed tomography (CT) or magnetic resonance imaging (MRI), and patients may develop local recurrence despite surgical procedures based on clinical stage. Pre-operative the patient and in the management of local disease. In clinical practice, pre-operative CT and MRI provide information about tumor size, tumor localization, presence of tumor invasion into vascular structures and adjacent organs. However, apart from these frequently reported findings, there are CT and MRI findings that can be used to predict advanced disease. In the 2017 Tumor, node, metastasis (TNM) classification, invasion of the pelvicalyceal system, perirenal or renal sinus fat invasion has been included in the T3a category. There are studies evaluating predictive value of CT to indicate renal sinus fat or perirenal fat invasion. Although not in the standard TNM classification, it has been shown that renal capsule invasion is an independent prognostic variable for advanced disease and can be detected on CT. On the other hand, it has been indicated that thickening of the Gerota's fascia, the presence of enlarged collateral vessels, and the presence of intra-tumoral necrosis may be imaging findings that can be used to predict advanced disease. The investigators think that the markers evaluated so far in pre-operative imaging and some additional markers may predict advanced disease in RCC. The investigators also think that the predictive value of MRI may be higher than CT. Therefore, in this study the investigators evaluated some predictive features (Renal capsule invasion, perirenal fat invasion, thickening of the Gerota's fascia, presence of enlarged collateral vessels, tumor necrosis, perinephric stranding) of pre-operative computed tomography and magnetic resonance imaging for advanced disease in renal cell carcinoma.
- Conditions
- Renal Malignant Tumor
- Being tested
- No intervention will be applied.
- Keywords
- Renal Cell Carcinoma, Tomography, Magnetic resonance imaging
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be applied.Other
The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined.
| Study group | Role | What they receive |
|---|---|---|
| pathological tumor stage 1-2 (pT1-2) | Stage pT1 and pT2 according to pathology results of patients who underwent partial or radical nephrectomy. Receives: Other: No intervention will be applied. | |
| pathological tumor stage ≥pT3a | Stage ≥pT3a according to pathology results of patients who underwent partial or radical nephrectomy. Receives: Other: No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 May 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Malignant TumorStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, selman unal, Ankara Yildirim Beyazıt University
- Investigators
- Selman Unal, Principal investigator, Ankara Yildirim Beyazit University School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042089
- Sponsor's protocol ID
- AnkaraYBU-URO-SU-03
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Features of Pre-operative Computed Tomography and Magnetic Resonance Imaging for Advanced Disease in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05042089
- Acronym / sponsor ID
- AnkaraYBU-URO-SU-03
- Conditions
- Renal Malignant Tumor
- Keywords
- Renal Cell Carcinoma, Tomography, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Renal cell carcinoma (RCC) is one of the most common urinary system cancers and accounts for 3% of all cancers. With the frequent use of imaging methods most renal masses are detected localized. The standard treatment option in localized RCC is radical nephrectomy (RN) or nephron-sparing surgery (NSS). NSS is preferred when appropriate in patients with tumor stage 1 (T1) and has been shown to be comparable to RN in terms of oncologic outcomes. Although there is no prospective randomized study comparing NSS with RN in terms of oncological and renal functions in T2 patients, there are retrospective studies conducted to date. According to the current European urology guideline, the standard approach in patients with T2 and above is RN. Pre-operative clinical staging is performed with computed tomography (CT) or magnetic resonance imaging (MRI), and patients may develop local recurrence despite surgical procedures based on clinical stage. Pre-operative the patient and in the management of local disease. In clinical practice, pre-operative CT and MRI provide information about tumor size, tumor localization, presence of tumor invasion into vascular structures and adjacent organs. However, apart from these frequently reported findings, there are CT and MRI findings that can be used to predict advanced disease. In the 2017 Tumor, node, metastasis (TNM) classification, invasion of the pelvicalyceal system, perirenal or renal sinus fat invasion has been included in the T3a category. There are studies evaluating predictive value of CT to indicate renal sinus fat or perirenal fat invasion. Although not in the standard TNM classification, it has been shown that renal capsule invasion is an independent prognostic variable for advanced disease and can be detected on CT. On the other hand, it has been indicated that thickening of the Gerota's fascia, the presence of enlarged collateral vessels, and the presence of intra-tumoral necrosis may be imaging findings that can be used to predict advanced disease. The investigators think that the markers evaluated so far in pre-operative imaging and some additional markers may predict advanced disease in RCC. The investigators also think that the predictive value of MRI may be higher than CT. Therefore, in this study the investigators evaluated some predictive features (Renal capsule invasion, perirenal fat invasion, thickening of the Gerota's fascia, presence of enlarged collateral vessels, tumor necrosis, perinephric stranding) of pre-operative computed tomography and magnetic resonance imaging for advanced disease in renal cell carcinoma.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pathological tumor stage 1-2 (pT1-2) | – | Other: No intervention will be applied.Stage pT1 and pT2 according to pathology results of patients who underwent partial or radical nephrectomy. |
| pathological tumor stage ≥pT3a | – | Other: No intervention will be applied.Stage ≥pT3a according to pathology results of patients who underwent partial or radical nephrectomy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients operated for kidney mass
- patients with preoperative CT or MRI imaging
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be applied.The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined. | Other | pathological tumor stage 1-2 (pT1-2), pathological tumor stage ≥pT3a |
Primary outcome
Renal capsule invasion
Time frame: 1 month
Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) renal capsule invasion.
Perirenal fat tissue invasion
Time frame: 1 month
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
Thickening of the Gerota's fascia
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selman Unal principal investigator
Ankara Yildirim Beyazit University School of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Malignant Tumor, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal capsule invasion (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.