Clinical trial NCT04040530: Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours
Official title: Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma
Quality of Life
Keywords: Renal Cell Carcinoma
Nephron sparing treatment
Quality of life
Patient Reported Outcome Measures
Kidney Neoplasms
Cryosurgery
Lead sponsor: Region of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region Zealand
First posted: 2019-07-31
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients diagnosed with dementia.
* Patients with tumours \> 7 cm.

Primary outcomes:
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)
timeFrame: Change from baseline at 14 days and 3 months postoperatively.
measure: Change from baseline in health-related Quality of life (HRQoL) to 3 months after treatment measured by the validated Danish version of SF-12v2.
timeFrame: 3 months
measure: Self evaluation of rehabilitation and experience of course of treatment measured by a locally validated questionnaire.
timeFrame: 3 months
measure: Number of participants with treatment related complications within the first 30 days after treatment.
timeFrame: 30 days
measure: Number of participants with treatment related complications between 30 and 90 days after treatment.
timeFrame: From 30 to 90 days postoperatively
measure: Number of participants who are readmitted to the hospital after discharge from treatment.
timeFrame: Within the first 30 days postoperatively
measure: Treatment success
timeFrame: 3 months
Secondary outcomes:
measure: Length of hospital stay after nephron sparing treatment
timeFrame: up to 90 days
measure: Rate of in-hospital mortality
timeFrame: up to 90 days
measure: Rate of cancer related mortality
timeFrame: Minimum of 3 months follow-up and up to 5 years.
measure: Change from baseline in health-related Quality of life measured by the validated Danish version of EORTC QLQ C-30.
timeFrame: Change from baseline at 1-5 years postoperatively.
measure: Change from baseline in health-related Quality of life (HRQoL) measured by the validated Danish version of SF-12v2.
timeFrame: Change from baseline at 1-5 years postoperatively.
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Region of Sourthern Denmark, Odense University Hospital
name: Theresa Junker, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Region of Sourthern Denmark, Odense University Hospital
name: Ole Graumann, MD, PhD
role: STUDY_DIRECTOR
References: