Clinical outcomes for patients diagnosed with renal cancer and caval thrombus involvement considering surgery
| ISRCTN | ISRCTN23209146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23209146 |
| Secondary identifying numbers | No 1057, Imperial College Healthcare NHS Trust |
- Submission date
- 09/01/2025
- Registration date
- 07/07/2025
- Last edited
- 07/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
There is considerable uncertainty on how best to treat and select the patients for this high-risk surgery. Surprisingly, the current UK surgical practice of this operation is largely unknown. This lack of knowledge creates a challenge in providing information and optimal care to patients.
This study is the UK’s first multicentre prospective surgical registry dedicated to improving the care of patients with kidney cancer with caval extension. The researchers will collect detailed information on patients' pre- and post-operative journey, understanding the impact of their surgery and seek information on contemporary surgical practice across the country. In addition, the researchers will collate real-world risks associated with surgery. After 18 months they will hold a national meeting using their results and others in the field using a validated consensus methodology to generate a set of clinical recommendations and create a standard operating procedure for this form of surgery. This will help to provide contemporary informed risks and benefits to patients and places improving patient care from high-risk surgery at the core of the project. Finally, the researchers will generate a patient information leaflet for this form of surgery which they hope can be adopted nationally (e.g. British Association of Urological Surgeons).
Who can participate?
Any person over the age of 18 referred to a specialist cancer meeting in a hospital that is involved in the study and has a new diagnosis of suspected renal cancer with a tumour clot (caval thrombus) involvement
What does the study involve?
Patients will undergo routine NHS care and data will be collected from their routine NHS visits.
What are the possible benefits and risks of participating?
There are no additional visits or requirements from the patient above that of routine practice. No changes in patient care result from this study that is observing current practice. No material risk exists to the patient.
Where is the study run from?
Imperial College Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
September 2024 to January 2027
Who is funding the study?
The Urology Foundation (TUF) (UK)
Who is the main contact?
Mr Martin Connor, m.connor@imperial.ac.uk
Contact information
Public, Principal Investigator
Charing Cross Hospital
Department of Surgery and Cancer
London
W6 8RF
United Kingdom
 ORCID ID |
0000-0003-4033-7508 |
|---|---|
| Phone | +44 (0)20 3311 1234 |
| m.connor@imperial.ac.uk |
Scientific
Charing Cross Hospital
Imperial College Healthcare NHS Trust
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 3311 1234 |
|---|---|
| ahughes-hallett@nhs.net |
Study information
| Study design | Multicenter registry study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Clinical outcomes for CAVAL THROMbus involved Renal Cell Cancer (Imperial Renal 1 – CAVALThromb): a prospective, multicentre registry |
| Study acronym | IR1-CAVALThromb |
| Study objectives | The project is aimed to improve our knowledge and understanding of the optimal surgical treatment for patients with renal cell carcinoma with inferior vena cava involvement |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | As an evaluation of current surgical practice, requirements for formal ethics committee approval were waived by the UK NHS Health Research Authority patients. The registry will be implemented and reported in accordance with the ethical principles of the Declaration of Helsinki. IR1-CAVALThomb will be registered at each side using the current NHS service evaluation forms with associated reference numbers prior to commencing work. |
| Health condition(s) or problem(s) studied | Renal cell carcinoma with inferior vena cava thrombus involvement |
| Intervention | IR1-CAVALThromb is a prospective, multicenter, registry study. The researchers plan to invite several centers to the register. They will collect data on patients who undergo radical nephrectomy with caval thrombectomy and non-surgical treatments for their advanced renal cancer. Broadly the researchers will look at: 1. Patient-reported and baseline clinical outcomes 2. Intraoperative outcomes 3. Adverse events recorded using the Clavien-Dindo classification 4. Oncological outcomes |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Standard operating procedure (SOP) for radical nephrectomy and caval thrombectomy surgery generated using the RAND/University of California at Los Angeles (UCLA) appropriateness method, completed once the last patient recruited has reached 3-month follow-up |
| Secondary outcome measures | 1. Morbidity of patients undergoing surgery and those who do not undergo immediate operative management assessed using the Clavien-Dindo Classification and/or the common terminology criteria for adverse events (CTCAEv5.0) at 3-month follow-up 2. Patient-reported outcome measures and health-reported quality-of-life measured using: 2.1. Clinical frailty score at baseline and 3-month follow-up 2.2. EORTC QLQ-F17 and EQ-5D-5L validated questionnaire at baseline and 3-month follow-up 3. Surgical complications assessed using the Clavien-Dindo Classification of patients at 3 months follow-up 4. Key recommendations for optimal patient care and objectives for further research developed using the RAND/University of California at Los Angeles (UCLA) appropriateness method, completed once the last patient recruited has reached 3-month follow-up |
| Overall study start date | 01/09/2024 |
| Completion date | 20/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Any person over the age of 18 years referred to a supra-regional MDT following a new diagnosis of suspected caval thrombus involved renal cancer |
| Key exclusion criteria | 1. Age under 18 years old 2. Patients who are found to have no evidence of caval thrombus on dedicated tertiary imaging |
| Date of first enrolment | 20/01/2025 |
| Date of final enrolment | 20/01/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W6 8RF
United Kingdom
London
SW3 6JJ
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Sponsor information
Hospital/treatment centre
Charing Cross Hospital
London
W6 8RF
England
United Kingdom
| Phone | +44 (0)20 3311 1234 |
|---|---|
| m.connor@imperial.ac.uk | |
| Website | http://www.imperial.nhs.uk/ |
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- TUF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 20/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed journal 2. Presentation at uro-oncology conferences in the United Kingdom and internationally. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the small number of patients and the risk of identifiable data |
Editorial Notes
09/01/2025: Study's existence confirmed by the Urology Foundation.
