NCT04040530

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2026

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

June 25, 2019

Last Update Submit

November 15, 2023

Conditions

Renal Cell CarcinomaQuality of Life

Keywords

Renal Cell CarcinomaNephron sparing treatmentQuality of lifePatient Reported Outcome MeasuresKidney NeoplasmsCryosurgery

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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

    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.

    3 months

Secondary Outcomes (5)

  • Length of hospital stay after nephron sparing treatment

    up to 90 days

  • Rate of in-hospital mortality

    up to 90 days

  • Rate of cancer related mortality

    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.

    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.

    Change from baseline at 1-5 years postoperatively.

Study Arms (2)

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.

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.

Procedure: Partial nephrectomy

Interventions

CT-guided cryoablationPROCEDURE

Percutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia.

Cryoablation
Partial nephrectomyPROCEDURE

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.

Partial nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University Hospital

Odense C, 5000, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Theresa Junker, PhD-student

    Region of Sourthern Denmark, Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Ole Graumann, MD, PhD

    Region of Sourthern Denmark, Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 31, 2019

Study Start

June 7, 2019

Primary Completion

February 7, 2021

Study Completion

February 7, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)