Renal Cell CarcinomaNCT05486871
Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
A study testing laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC . Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2022to 20 Aug 2024
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a).
Who cannot join
- Patients who had other tumors
- benign tumors
- clinically unfit
- metastatic RCC
- patients with Clinical T2b or higher tumors,
- tumors with maximum diameter > 10cm
Trial locations and contacts
1 site in 1 country.
Mohamed s Saleem, professor contact
About this study
RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC .
The EUA guidelines recommend PN for patients with T1 tumors, as PN preserved kidney function better after surgery, thereby potentially lowering the risk of development of cardiovascular disorders as well as improving overall survival(OS) for PN compared to RN, there is very limited evidence on the optimal surgical treatment for patients with larger renal masses (T2) .
Currently, the upper limit of PN indications remains undefined and is determined by an individual surgeon's expertise and preference. The degree of variability in the choice between PN and RN for a given tumor increases with tumor size. Surgeons committed to nephron-sparing are likely to expand the indications of PN, while those concerned with increased morbidity and doubtful of the clinical relevance of a moderate decrease in renal function are likely to perform RN, regardless of tumor size .
- Conditions
- Renal Cell Carcinoma
- Being tested
- laparoscopic partial nephrectomy
- 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.
laparoscopic partial nephrectomyProcedure or surgery
This is a prospective non- randomized controlled study of patients with RCC Who will be referred to urology department, Sohag university hospital. Our comparative study contained two groups according to tumor stage at preoperative contrast study:
Group [A] : 15 patients with T1 RCC (≤ 7 cm). Group [B] : 15 patients with T2a RCC (≤ 10 cm). the patients will be subjected to laparoscopic partial nephrectomy then will be followed up for two years for oncological and functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| renal cell carcinoma stages T1 | Active comparator | laparoscopic partial nephrectomy in renal cell carcinoma stage T1 Receives: Procedure: laparoscopic partial nephrectomy |
| renal cell carcinoma stages T2a | Active comparator | laparoscopic partial nephrectomy in renal cell carcinoma stage T2a Receives: Procedure: laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function.
Patients' pre and postoperative eGFR values were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, with the postoperative eGFR based on the creatinine measurement taken closest to 1 yr after surgery (between 9 and 15 month postoperatively). The eGFR downgrade was defined as preoperative eGFR 60 ml/min/1.73 m2 and postoperative eGFR <60 ml/min/1.73 m2 at 1 yr after surgery.
Measured: 3month
Post-operative complications.
complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Measured: 3 month
Local recurrence.
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
Measured: 3 month
Distant metastases.
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine and bone scan incase of bone pain or pathological fractures CT BRAIN incase of manifestation of increased intracranial tension
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start20 Aug 2022 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Attia, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486871
- Sponsor's protocol ID
- Soh-Med-22-07-20
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.
PubMed 30100160Vilaseca A, Guglielmetti G, Vertosick EA, Sjoberg DD, Grasso A, Benfante NE, Nguyen DP, Corradi RB, Coleman J, Russo P, Vickers AJ, Touijer KA. Value of Partial Nephrectomy for Renal Cortical Tumors of cT2 or Greater Stage: A Risk-benefit Analysis of Renal Function Preservation Versus Increased Postoperative Morbidity. Eur Urol Oncol. 2020 Jun;3(3):365-371. doi: 10.1016/j.euo.2019.04.003. Epub 2019 Apr 30.
PubMed 31411969Munoz-Rodriguez J, Prera A, Dominguez A, de Verdonces L, Rosado MA, Martos R, Prats J. Laparoscopic partial nephrectomy: Comparative study of the transperitoneal pathway and the retroperitoneal pathway. Actas Urol Esp (Engl Ed). 2018 May;42(4):273-279. doi: 10.1016/j.acuro.2017.09.008. Epub 2017 Nov 21. English, Spanish.
PubMed 29169703Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, Gore JL, Sun M, Wood C, Russo P. Epidemiology of Renal Cell Carcinoma. Eur Urol. 2019 Jan;75(1):74-84. doi: 10.1016/j.eururo.2018.08.036. Epub 2018 Sep 19.
PubMed 30243799
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT05486871
- Acronym / sponsor ID
- Soh-Med-22-07-20
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 4 Aug 2022 (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.
RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC .
The EUA guidelines recommend PN for patients with T1 tumors, as PN preserved kidney function better after surgery, thereby potentially lowering the risk of development of cardiovascular disorders as well as improving overall survival(OS) for PN compared to RN, there is very limited evidence on the optimal surgical treatment for patients with larger renal masses (T2) .
Currently, the upper limit of PN indications remains undefined and is determined by an individual surgeon's expertise and preference. The degree of variability in the choice between PN and RN for a given tumor increases with tumor size. Surgeons committed to nephron-sparing are likely to expand the indications of PN, while those concerned with increased morbidity and doubtful of the clinical relevance of a moderate decrease in renal function are likely to perform RN, regardless of tumor size .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal cell carcinoma stages T1 | Active comparator | Procedure: laparoscopic partial nephrectomylaparoscopic partial nephrectomy in renal cell carcinoma stage T1 |
| renal cell carcinoma stages T2a | Active comparator | Procedure: laparoscopic partial nephrectomylaparoscopic partial nephrectomy in renal cell carcinoma stage T2a |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a).
Key exclusion criteria (6 listed)
- Patients who had other tumors
- benign tumors
- clinically unfit
- metastatic RCC
- patients with Clinical T2b or higher tumors,
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 |
|---|---|---|
| laparoscopic partial nephrectomyThis is a prospective non- randomized controlled study of patients with RCC Who will be referred to urology department, Sohag university hospital. Our comparative study contained two groups according to tumor stage at preoperative contrast study: Group [A] : 15 patients with T1 RCC (≤ 7 cm). Group [B] : 15 patients with T2a RCC (≤ 10 cm). the patients will be subjected to laparoscopic partial nephrectomy then will be followed up for two years for oncological and functional outcomes. | Procedure or surgery | renal cell carcinoma stages T1, renal cell carcinoma stages T2a |
Primary outcome
Renal function.
Time frame: 3month
Patients' pre and postoperative eGFR values were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, with the postoperative eGFR based on the creatinine measurement taken closest to 1 yr after surgery (between 9 and 15 month postoperatively). The eGFR downgrade was defined as preoperative eGFR 60 ml/min/1.73 m2 and postoperative eGFR <60 ml/min/1.73 m2 at 1 yr after surgery.
Post-operative complications.
Time frame: 3 month
complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Local recurrence.
Time frame: 3 month
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
Distant metastases.
Time frame: 3 month
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine and bone scan incase of bone pain or pathological fractures CT BRAIN incase of manifestation of increased intracranial tension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 30100160Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.
- Background: PubMed 31411969Vilaseca A, Guglielmetti G, Vertosick EA, Sjoberg DD, Grasso A, Benfante NE, Nguyen DP, Corradi RB, Coleman J, Russo P, Vickers AJ, Touijer KA. Value of Partial Nephrectomy for Renal Cortical Tumors of cT2 or Greater Stage: A Risk-benefit Analysis of Renal Function Preservation Versus Increased Postoperative Morbidity. Eur Urol Oncol. 2020 Jun;3(3):365-371. doi: 10.1016/j.euo.2019.04.003. Epub 2019 Apr 30.
- Background: PubMed 29169703Munoz-Rodriguez J, Prera A, Dominguez A, de Verdonces L, Rosado MA, Martos R, Prats J. Laparoscopic partial nephrectomy: Comparative study of the transperitoneal pathway and the retroperitoneal pathway. Actas Urol Esp (Engl Ed). 2018 May;42(4):273-279. doi: 10.1016/j.acuro.2017.09.008. Epub 2017 Nov 21. English, Spanish.
- Background: PubMed 30243799Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, Gore JL, Sun M, Wood C, Russo P. Epidemiology of Renal Cell Carcinoma. Eur Urol. 2019 Jan;75(1):74-84. doi: 10.1016/j.eururo.2018.08.036. Epub 2018 Sep 19.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed s Saleem, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Attia, assisstent lecturer (01000962381, ahmed.attia@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function. (time frame: 3month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486871, which also lists 4 linked publications.
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 4 Aug 2022.