Renal Cell CarcinomaNCT04040530
Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours
An observational study of Renal Cell Carcinoma and Quality of Life, run by Region of Southern Denmark at 2 sites in Denmark.
Trial summary
The present study is an observational study designed to assess and compare clinical outcome and quality of life after nephron sparing treatment of small renal tumors. Partial nephrectomy, where the tumor is being be surgically removed, has traditionally been the preferred nephron sparing treatment for small renal cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Quality of Life
- What is being tested?
- CT-guided cryoablation and Partial nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 Jun 2019to 7 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from the Department of Urology at Odense University Hospital and Zealand University Hospital based in The Region of Southern Denmark and Region Zealand respectively. Odense University Hospital and Zealand University Hospital are the only centers offering nephron sparing treatment for renal cell carcinomas within the two regions. The Region of Southern Denmark and Region Zealand are two out of the five regions in Denmark. They have a population of about 2 million people combined. The population of the regions are considered demographic comparable.
Who may be able to join
- Patients undergoing CT-guided cryoablation of histologically verified primary renal cancer at stage T1
- Patients undergoing partial nephrectomy of histologically verified primary renal cancer at stage T1
- Patients who understand and read Danish.
Who cannot join
- Patients diagnosed with dementia.
- Patients with tumours > 7 cm.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Odense University Hospital
Odense C, 5000
Zealand University Hospital
Roskilde, 4000
About this study
The present study is an observational study designed to assess and compare clinical outcome and quality of life after nephron sparing treatment of small renal tumors.
Partial nephrectomy, where the tumor is being be surgically removed, has traditionally been the preferred nephron sparing treatment for small renal cell carcinomas (RCC). Cryoablation was introduced 20 years ago as a treatment option for patients with RCC with a high surgical risk. Previously, this group of patients had no available treatment. Cryoablation is a minimally invasive treatment that uses extreme cold to destroy the cancer. In recent years, indications for cryoablation of RCC has extended. Cryoablation is now offered as a curative treatment, also including patients without severe comorbidity.
Read more
Retrospective studies imply that patients with RCC have lower quality of life compared to other cancers and that choice of treatment and remaining healthy renal tissue have a correlation with quality of life. Knowledge about the patient perspective is crucial in relation to delivering the highest quality of care in the healthcare system. Exploring quality of life through patient reported outcome is one way of exploring the patient perspective.
In this prospective study the investigators aim to assess clinical outcome and quality of life after partial nephrectomy and cryoablation. Results are expected to generate evidence-based knowledge essential in treatment decisions for RCC globally.
Read the detailed description
The overall aim of this prospective study is to assess and compare clinical outcome and health related quality of life after partial nephrectomy and cryoablation of renal tumors at stadium T1 in adult patients. The specific objectives is:
- To describe treatment characteristics (treatment type, knife time, type of anaesthesia) with i) cryoablation and ii) partial nephrectomy on patients with T1 renal tumors in the Regions of Southern Denmark and Zealand.
- To describe self-reported health related quality of life in adult patients with T1 renal tumors undergoing i) cryoablation and ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
- To compare patient and tumor characteristics (age, sex, BMI, performance status, American Society of Anaesthesiologists' (ASA) classification group, comorbidity, other cancer diagnosis, smoking and alcohol use, tumor location and size, and tumor histology) in patients with T1 renal tumors treated with i) Cryoablation or ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
- To compare complications, length of hospital stay, treatment success within follow-up, readmission rate and in-hospital mortality after after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
- To compare self reported quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
- To identify potential patient or tumor characteristics reducing quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
All eligible patients will be offered inclusion. Patients will be allocated to treatment group based on shared decision making between the patient and the treating urologist and recommendation from a multidisciplinary team conference. This reflecting the clinical practice.
- Conditions
- Renal Cell Carcinoma, Quality of Life
- Being tested
- CT-guided cryoablation, Partial nephrectomy
- Keywords
- Renal Cell Carcinoma, Nephron sparing treatment, Quality of life, Patient Reported Outcome Measures, Kidney Neoplasms, Cryosurgery
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided cryoablationProcedure or surgery
Percutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia.
Partial nephrectomyProcedure or surgery
Surgical removal of the renal cancer, leaving the healthy renal tissue. Surgery is either done laparoscopically, robot-assisted laparoscopically or as an open surgery. The patient is under general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Consecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with CT-guided cryoablation at Odense University Hospital in the period from 1/6-2019 to 1/6-2021. Receives: Procedure: CT-guided cryoablation | |
| Partial nephrectomy | Consecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with partial nephrectomy at Odense University Hospital or Zealand University Hospital in the period from 1/6-2019 to 1/6-2021. Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in health-related Quality of life measured by the validated Danish version of The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30)
EORTC QLQ C- 30 will be used for quality of life measurement. A scale range 0-100, a higher score indicating better quality of life within five functional scales ( physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale and the following six single item symptom measures; dyspnea, insomnia, appetite loss, constipation, diarrhea, and functional difficulties.
Measured: Change from baseline at 14 days and 3 months postoperatively.
Change from baseline in health-related Quality of life (HRQoL) to 3 months after treatment measured by the validated Danish version of SF-12v2.
HRQoL will be assessed by the Short Form 12 version 2.0 (SF-12v2) Health Survey scores.
Measured: 3 months
Self evaluation of rehabilitation and experience of course of treatment measured by a locally validated questionnaire.
Patients' self evaluation of rehabilitation and course of treatment will be assessed by the locally validated rehabilitation questionnaire for renal cancer (RQRC). The questionnaire consists of seven items. Responses will be reported in percentages.
Measured: 3 months
Number of participants with treatment related complications within the first 30 days after treatment.
Graded and classified according to the Clavien-Dindo classification.
Measured: 30 days
Number of participants with treatment related complications between 30 and 90 days after treatment.
Graded and classified according to the Clavien-Dindo classification.
Measured: From 30 to 90 days postoperatively
Number of participants who are readmitted to the hospital after discharge from treatment.
Readmission to the hospital after discharge
Measured: Within the first 30 days postoperatively
Treatment success
The degree of incomplete ablation after cryoablation, visualized on CT, in comparison with the degree of positive surgical margin after partial nephrectomy, from histopathology.
Measured: 3 months
Secondary outcomes (5)
Length of hospital stay after nephron sparing treatment
Absolute number of days the patient is hospitalized after treatment.
Measured: up to 90 days
Rate of in-hospital mortality
Mortality under hospitalization after initial treatment
Measured: up to 90 days
Rate of cancer related mortality
Cancer related mortality calculated from the date of treatment, to the date of death related to renal cell carcinoma or censored at the date at last follow-up.
Measured: Minimum of 3 months follow-up and up to 5 years.
Change from baseline in health-related Quality of life measured by the validated Danish version of EORTC QLQ C-30.
The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30) will be used for quality of life measurement. A scale range 0-100, a higher score indicating better quality of life within five functional scales ( physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale and the following six single item symptom measures; dyspnea, insomnia, appetite loss, constipation, diarrhea, and functional difficulties.
Measured: Change from baseline at 1-5 years postoperatively.
Change from baseline in health-related Quality of life (HRQoL) measured by the validated Danish version of SF-12v2.
HRQoL will be assessed by the Short Form 12 version 2.0 (SF-12v2) Health Survey scores.
Measured: Change from baseline at 1-5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start7 Jun 2019
- Primary completion7 Feb 2021
- Study completion7 Feb 2026 (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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region Zealand
- Responsible party
- Principal investigator, Theresa Junker, Region of Southern Denmark
- Investigators
- Theresa Junker, PhD-student, Principal investigator, Region of Sourthern Denmark, Odense University HospitalOle Graumann, MD, PhD, Study director, Region of Sourthern Denmark, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040530
- Sponsor's protocol ID
- Nephspare PRO
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2019
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours
- ClinicalTrials.gov ID
- NCT04040530
- Acronym / sponsor ID
- Nephspare PRO
- Conditions
- Renal Cell Carcinoma, Quality of Life
- Keywords
- Renal Cell Carcinoma, Nephron sparing treatment, Quality of life, Patient Reported Outcome Measures, Kidney Neoplasms, Cryosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region Zealand
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 7 Feb 2021 (actual)
- Study completion
- 7 Feb 2026 (estimated)
- First posted
- 31 Jul 2019 (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 present study is an observational study designed to assess and compare clinical outcome and quality of life after nephron sparing treatment of small renal tumors.
Partial nephrectomy, where the tumor is being be surgically removed, has traditionally been the preferred nephron sparing treatment for small renal cell carcinomas (RCC). Cryoablation was introduced 20 years ago as a treatment option for patients with RCC with a high surgical risk. Previously, this group of patients had no available treatment. Cryoablation is a minimally invasive treatment that uses extreme cold to destroy the cancer. In recent years, indications for cryoablation of RCC has extended. Cryoablation is now offered as a curative treatment, also including patients without severe comorbidity.
Retrospective studies imply that patients with RCC have lower quality of life compared to other cancers and that choice of treatment and remaining healthy renal tissue have a correlation with quality of life. Knowledge about the patient perspective is crucial in relation to delivering the highest quality of care in the healthcare system. Exploring quality of life through patient reported outcome is one way of exploring the patient perspective.
In this prospective study the investigators aim to assess clinical outcome and quality of life after partial nephrectomy and cryoablation. Results are expected to generate evidence-based knowledge essential in treatment decisions for RCC globally.
Detailed description
The overall aim of this prospective study is to assess and compare clinical outcome and health related quality of life after partial nephrectomy and cryoablation of renal tumors at stadium T1 in adult patients. The specific objectives is:
- To describe treatment characteristics (treatment type, knife time, type of anaesthesia) with i) cryoablation and ii) partial nephrectomy on patients with T1 renal tumors in the Regions of Southern Denmark and Zealand.
- To describe self-reported health related quality of life in adult patients with T1 renal tumors undergoing i) cryoablation and ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
- To compare patient and tumor characteristics (age, sex, BMI, performance status, American Society of Anaesthesiologists' (ASA) classification group, comorbidity, other cancer diagnosis, smoking and alcohol use, tumor location and size, and tumor histology) in patients with T1 renal tumors treated with i) Cryoablation or ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
- To compare complications, length of hospital stay, treatment success within follow-up, readmission rate and in-hospital mortality after after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
- To compare self reported quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
- To identify potential patient or tumor characteristics reducing quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
All eligible patients will be offered inclusion. Patients will be allocated to treatment group based on shared decision making between the patient and the treating urologist and recommendation from a multidisciplinary team conference. This reflecting the clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | – | Procedure: CT-guided cryoablationConsecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with CT-guided cryoablation at Odense University Hospital in the period from 1/6-2019 to 1/6-2021. |
| Partial nephrectomy | – | Procedure: Partial nephrectomyConsecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with partial nephrectomy at Odense University Hospital or Zealand University Hospital in the period from 1/6-2019 to 1/6-2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from the Department of Urology at Odense University Hospital and Zealand University Hospital based in The Region of Southern Denmark and Region Zealand respectively. Odense University Hospital and Zealand University Hospital are the only centers offering nephron sparing treatment for renal cell carcinomas within the two regions. The Region of Southern Denmark and Region Zealand are two out of the five regions in Denmark. They have a population of about 2 million people combined. The population of the regions are considered demographic comparable.
Key inclusion criteria (3 listed)
- Patients undergoing CT-guided cryoablation of histologically verified primary renal cancer at stage T1
- Patients undergoing partial nephrectomy of histologically verified primary renal cancer at stage T1
- Patients who understand and read Danish.
Key exclusion criteria (2 listed)
- Patients diagnosed with dementia.
- Patients with tumours > 7 cm.
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 |
|---|---|---|
| CT-guided cryoablationPercutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia. | Procedure or surgery | Cryoablation |
| Partial nephrectomySurgical removal of the renal cancer, leaving the healthy renal tissue. Surgery is either done laparoscopically, robot-assisted laparoscopically or as an open surgery. The patient is under general anaesthesia. | Procedure or surgery | Partial nephrectomy |
Primary outcome
Change from baseline in health-related Quality of life measured by the validated Danish version of The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30)
Time frame: Change from baseline at 14 days and 3 months postoperatively.
EORTC QLQ C- 30 will be used for quality of life measurement. A scale range 0-100, a higher score indicating better quality of life within five functional scales ( physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale and the following six single item symptom measures; dyspnea, insomnia, appetite loss, constipation, diarrhea, and functional difficulties.
Change from baseline in health-related Quality of life (HRQoL) to 3 months after treatment measured by the validated Danish version of SF-12v2.
Time frame: 3 months
HRQoL will be assessed by the Short Form 12 version 2.0 (SF-12v2) Health Survey scores.
Self evaluation of rehabilitation and experience of course of treatment measured by a locally validated questionnaire.
Time frame: 3 months
Patients' self evaluation of rehabilitation and course of treatment will be assessed by the locally validated rehabilitation questionnaire for renal cancer (RQRC). The questionnaire consists of seven items. Responses will be reported in percentages.
Number of participants with treatment related complications within the first 30 days after treatment.
Time frame: 30 days
Graded and classified according to the Clavien-Dindo classification.
Number of participants with treatment related complications between 30 and 90 days after treatment.
Time frame: From 30 to 90 days postoperatively
Graded and classified according to the Clavien-Dindo classification.
Number of participants who are readmitted to the hospital after discharge from treatment.
Time frame: Within the first 30 days postoperatively
Readmission to the hospital after discharge
Treatment success
Time frame: 3 months
The degree of incomplete ablation after cryoablation, visualized on CT, in comparison with the degree of positive surgical margin after partial nephrectomy, from histopathology.
5 secondary outcomes
Length of hospital stay after nephron sparing treatment
Time frame: up to 90 days
Rate of in-hospital mortality
Time frame: up to 90 days
Rate of cancer related mortality
Time frame: Minimum of 3 months follow-up and up to 5 years.
Change from baseline in health-related Quality of life measured by the validated Danish version of EORTC QLQ C-30.
Time frame: Change from baseline at 1-5 years postoperatively.
Change from baseline in health-related Quality of life (HRQoL) measured by the validated Danish version of SF-12v2.
Time frame: Change from baseline at 1-5 years postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
Theresa Junker, PhD-student principal investigator
Region of Sourthern Denmark, Odense University Hospital
Ole Graumann, MD, PhD study director
Region of Sourthern Denmark, Odense University Hospital
2 sites 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 Quality of Life, run by Region of Southern Denmark at 2 sites in Denmark.
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 3 inclusion and 2 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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?
Change from baseline in health-related Quality of life measured by the validated Danish version of The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30) (time frame: Change from baseline at 14 days and 3 months postoperatively.). The study lists 7 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 18 Nov 2023.