Renal Cell CarcinomaNCT05887245
Clinical Significance of Adherent Perinephric Fat in Patients Undergoing Partial Nephrectomy
An observational study of Renal Cell Carcinoma and Kidney Neoplasm, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
The aim of this study is to gain a better understanding of the phenomenon of adherent perinephric fat (APF), which occurs in some patients undergoing partial nephrectomy (PN). This phenomenon, so-called "toxic fat", is a commonly recognized problem among urologists, but its significance has not yet been fully… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 17 Apr 2023to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a radiological diagnosis of kidney tumor referred for surgical treatment with partial nephrectomy will be eligible.
Who may be able to join
- Patients qualified for partial nephrectomy by open, laparoscopic, or robotic method
- Tumor stage cT1a-cT1b according to Tumour Node Metastasis classification
- Age ≥ 18 years
- Written consent to participate in the study
Who cannot join
- Patient does not give consent to participate in the study
- Patients with recurrent kidney cancer, or who have undergone other surgeries within the kidney
- Lack of preoperative imaging available for assessment
- Missing medical documentation that prevents data analysis
Trial locations and contacts
1 site in 1 country.
Poland1 site
European Health Centre, Second Department of Urology, Centre of Postgraduate Medical Education
Otwock, 05-400
About this study
Official title: Znaczenie Kliniczne przywierającego tłuszczu okołonerkowego u pacjentów Poddawanych Resekcji Guza Nerki
The aim of this study is to gain a better understanding of the phenomenon of adherent perinephric fat (APF), which occurs in some patients undergoing partial nephrectomy (PN). This phenomenon, so-called "toxic fat", is a commonly recognized problem among urologists, but its significance has not yet been fully understood. The study aims to identify new clinical risk factors for APF occurrence and evaluate its impact on functional, perioperative, and oncological treatment outcomes. The study will be conducted on patients who are qualified for PN surgery. Prior to the surgical procedure, venous blood will be collected, which will be used for various measurements, such as blood morphology, kidney parameters, inflammation markers, liver function tests, glucose, and lipid profile. In addition, medical data will be collected concerning the patient's overall health, observed changes in the kidney, perioperative course, hospitalization, and histopathological characteristics of the tumor. After treatment, patients will be followed up for up to 60 months. The knowledge gained from this study can significantly assist in making decisions about surgical treatment and thus contribute to improving the treatment outcomes of patients with kidney tumors.
Read the detailed description
Patients qualified for partial nephrectomy surgery based on radiological diagnosis of kidney tumor will be prospectively identified. Thirty milliliters of venous blood will be collected one day prior to the procedure. Blood samples will be sent to the laboratory, where, in addition to the standard preoperative tests (blood count, creatinine, urea, fasting glucose), the following parameters will be determined: C-reactive protein, ferritin, total cholesterol, low density lipoprotein, high density lipoprotein, and triglycerides. At the time of patient enrollment in the study, a clinical and demographic interview will be conducted. In addition, the hospital's electronic medical records will be used to obtain preoperative conventional imaging test results related to tumor characteristics. During the treatment, perioperative parameters will also be collected, including the presence of APF defined intraoperatively by the surgeon. APF is defined as "perinephric fat adherent to the renal parenchyma, making renal dissection difficult" with the presence defined by the surgeon as 1 - present, 0 - absent. The patient's participation in the study will not affect the type or technique of the surgery, and therefore, the risk of complications. After obtaining the histopathological result, data regarding the removed tumor will be collected. During the observation period (6, 12, 24, and 60 months after treatment), oncological and functional outcomes will be assessed and recorded. The observation will be conducted according to the treating physician's recommendations, in accordance with current medical knowledge, and its modification is not the subject of this study. Patient data will be collected and stored in an electronic database. The assessment of the relationship between the various blood parameters, demographic characteristics (age, gender), clinical characteristics (such as BMI, presence of metabolic syndrome, tumor size), and the presence of APF will be performed using univariate analysis (Chi-square, univariate logistic regression) and multivariate analysis (logistic regression models). When evaluating the impact of APF on perioperative and oncological outcomes, confounding variables (such as tumor stage, surgical method, surgeon) will be taken into account when creating predictive models.
- Conditions
- Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms, Urogenital Neoplasms, Kidney Diseases
- Keywords
- Partial Nephrectomy, Adherent Perinephric Fat
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical risk factors for the occurrence of adherent perinephric fat in patients undergoing partial nephrectomy.
The following variables will be evaluated:
- Anthropometric (sex; age in years; weight in kilograms; height in centimeters; waist circumference in centimeters) and comorbidity data (assessed with Charlson Comorbidity Index, 0-24).
- Laboratory test results (C-reactive protein in mg/l; total cholesterol in mg/dl; triglycerides in mg/dl; high density lipoprotein in mg/dl; low density lipoprotein in mg/dl; ferritin in ng/ml; fasting glucose in mg/dl; creatinine in mg/dl; glomerular filtration rate calculated with the Modification of Diet in Renal Disease equation in ml/min/1,73 m²; white blood cell in G/l; lymphocyte in G/l; monocyte in G/l; hemoglobin in g/dl; platelets in G/l; neutrophil in G/l).
- Imaging data and tumor features (maximum tumor diameter in millimeters; perirenal fat thickness in millimeters; Mayo Adhesive Probability score, 0 - 5; RENAL Nephrometry Score, 4 - 12).
Measured: Data gathered in the pre-operative period. Blood samples collected one day prior to surgery.
Secondary outcomes (1)
Evaluation of the impact of adherent perinephric fat on functional, perioperative, and oncological treatment outcomes.
The following variables will be evaluated:
- Peri-operative (operative time in minutes; warm ischemia time in minutes; estimated blood loss in minutes) and post-operative data (complications assessed with Clavien-Dindo Classification, I-V).
- Tumor histopathological characteristics (tumor type; maximum tumor diameter in millimeters; tumor stage according to the Tumour Node Metastasis classification; Fuhrman grade 1-4; surgical margins 0-1).
- Oncological (recurrence-free survival in months, overall survival in months), functional (estimated glomerular function change in ml/min/1,73 m²) outcomes.
Measured: Data gathered in the post-operative period. Observation period 6,12, 24, and 60 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start17 Apr 2023
- Primary completion17 Apr 2025
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sławomir Poletajew, Prof., Principal investigator, Second Department of Urology, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887245
- Sponsor's protocol ID
- nr 21/2023
- Status last verified
- Nov 2024
- First submitted
- 18 May 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Znaczenie Kliniczne przywierającego tłuszczu okołonerkowego u pacjentów Poddawanych Resekcji Guza Nerki
- ClinicalTrials.gov ID
- NCT05887245
- Acronym / sponsor ID
- nr 21/2023
- Conditions
- Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms, Urogenital Neoplasms, Kidney Diseases
- Keywords
- Partial Nephrectomy, Adherent Perinephric Fat
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 2 Jun 2023 (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 aim of this study is to gain a better understanding of the phenomenon of adherent perinephric fat (APF), which occurs in some patients undergoing partial nephrectomy (PN). This phenomenon, so-called "toxic fat", is a commonly recognized problem among urologists, but its significance has not yet been fully understood. The study aims to identify new clinical risk factors for APF occurrence and evaluate its impact on functional, perioperative, and oncological treatment outcomes. The study will be conducted on patients who are qualified for PN surgery. Prior to the surgical procedure, venous blood will be collected, which will be used for various measurements, such as blood morphology, kidney parameters, inflammation markers, liver function tests, glucose, and lipid profile. In addition, medical data will be collected concerning the patient's overall health, observed changes in the kidney, perioperative course, hospitalization, and histopathological characteristics of the tumor. After treatment, patients will be followed up for up to 60 months. The knowledge gained from this study can significantly assist in making decisions about surgical treatment and thus contribute to improving the treatment outcomes of patients with kidney tumors.
Detailed description
Patients qualified for partial nephrectomy surgery based on radiological diagnosis of kidney tumor will be prospectively identified. Thirty milliliters of venous blood will be collected one day prior to the procedure. Blood samples will be sent to the laboratory, where, in addition to the standard preoperative tests (blood count, creatinine, urea, fasting glucose), the following parameters will be determined: C-reactive protein, ferritin, total cholesterol, low density lipoprotein, high density lipoprotein, and triglycerides. At the time of patient enrollment in the study, a clinical and demographic interview will be conducted. In addition, the hospital's electronic medical records will be used to obtain preoperative conventional imaging test results related to tumor characteristics. During the treatment, perioperative parameters will also be collected, including the presence of APF defined intraoperatively by the surgeon. APF is defined as "perinephric fat adherent to the renal parenchyma, making renal dissection difficult" with the presence defined by the surgeon as 1 - present, 0 - absent. The patient's participation in the study will not affect the type or technique of the surgery, and therefore, the risk of complications. After obtaining the histopathological result, data regarding the removed tumor will be collected. During the observation period (6, 12, 24, and 60 months after treatment), oncological and functional outcomes will be assessed and recorded. The observation will be conducted according to the treating physician's recommendations, in accordance with current medical knowledge, and its modification is not the subject of this study. Patient data will be collected and stored in an electronic database. The assessment of the relationship between the various blood parameters, demographic characteristics (age, gender), clinical characteristics (such as BMI, presence of metabolic syndrome, tumor size), and the presence of APF will be performed using univariate analysis (Chi-square, univariate logistic regression) and multivariate analysis (logistic regression models). When evaluating the impact of APF on perioperative and oncological outcomes, confounding variables (such as tumor stage, surgical method, surgeon) will be taken into account when creating predictive models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a radiological diagnosis of kidney tumor referred for surgical treatment with partial nephrectomy will be eligible.
Key inclusion criteria (4 listed)
- Patients qualified for partial nephrectomy by open, laparoscopic, or robotic method
- Tumor stage cT1a-cT1b according to Tumour Node Metastasis classification
- Age ≥ 18 years
- Written consent to participate in the study
Key exclusion criteria (4 listed)
- Patient does not give consent to participate in the study
- Patients with recurrent kidney cancer, or who have undergone other surgeries within the kidney
- Lack of preoperative imaging available for assessment
- Missing medical documentation that prevents data analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of clinical risk factors for the occurrence of adherent perinephric fat in patients undergoing partial nephrectomy.
Time frame: Data gathered in the pre-operative period. Blood samples collected one day prior to surgery.
The following variables will be evaluated: 1. Anthropometric (sex; age in years; weight in kilograms; height in centimeters; waist circumference in centimeters) and comorbidity data (assessed with Charlson Comorbidity Index, 0-24). 2. Laboratory test results (C-reactive protein in mg/l; total cholesterol in mg/dl; triglycerides in mg/dl; high density lipoprotein in mg/dl; low density lipoprotein in mg/dl; ferritin in ng/ml; fasting glucose in mg/dl; creatinine in mg/dl; glomerular filtration rate calculated with the Modification of Diet in Renal Disease equation in ml/min/1,73 m²; white blood cell in G/l; lymphocyte in G/l; monocyte in G/l; hemoglobin in g/dl; platelets in G/l; neutrophil in G/l). 3. Imaging data and tumor features (maximum tumor diameter in millimeters; perirenal fat thickness in millimeters; Mayo Adhesive Probability score, 0 - 5; RENAL Nephrometry Score, 4 - 12).
1 secondary outcome
Evaluation of the impact of adherent perinephric fat on functional, perioperative, and oncological treatment outcomes.
Time frame: Data gathered in the post-operative period. Observation period 6,12, 24, and 60 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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.
Sławomir Poletajew, Prof. principal investigator
Second Department of Urology, Centre of Postgraduate Medical Education
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 Cell Carcinoma and Kidney Neoplasm, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Jun 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluation of clinical risk factors for the occurrence of adherent perinephric fat in patients undergoing partial nephrectomy. (time frame: Data gathered in the pre-operative period. Blood samples collected one day prior to surgery.). 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 27 Jun 2025.