A study looking at biomarkers before and after surgery of the prostate, bladder, penis or kidney

Cancer type:

Bladder cancer
Kidney cancer
Penile cancer
Prostate cancer

Status:

Open

Phase:

Other

Surgery is a treatment for cancer and non cancerous (benign) conditions of the prostate, bladder, penis and kidney. The number of people having this type of surgery is increasing.

This means that more people are at risk of complications after surgery. For example, bleeding and infection.  Also, an increasing number of those people with cancer have cancer that comes back (recurrence) or continues to grow.          

Doctors would like to find ways to monitor patients more closely. It would be useful to predict who is going to have a problem or complication after their treatment. And who is more likely to have recurrence.

More about this trial

Doctors can use surgery to remove

You may also have surgery to treat non cancerous (benign) conditions in these parts of the body.

Doctors think that one way to monitor patients more closely when they have surgery would be to use biomarkers. A biomarker Open a glossary item is a substance in the body that can be measured.

In this study, the researchers will look at people’s blood and urine samples before and after surgery to measure certain biomarkers.

The aims of this study are to

  • Find out if surgery of the prostate, bladder, penis and kidney causes changes to biomarkers in the body
  • See if there is a link between changes in these biomarkers and complications after surgery
  • See if there is a link between changes in these biomarkers and the cancer coming back

You will not directly benefit from taking part in this study. If the researchers find that biomarkers are useful, it could help to improve the care and treatment of other people in the future.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if one of the following apply. You

  • Are due to have surgery to treat cancer or a non cancerous (benign) condition of the prostate, bladder or kidney and you are a patient at either Wrexham Maelor Hospital, Glan Clwyd Hospital or Bangor Hospital in North Wales
  • Are due to have surgery to treat cancer or a non cancerous (benign) condition of the penis and you are a patient at University College London Hospital

Trial design

The researchers need 678 people to join.

You have your surgery as planned. Taking part in this study will not affect the type of operation you have. The only difference is that you have extra blood and urine samples taken as part of this study. Where possible the blood samples are taken at the same time as your routine blood tests.

Before surgery, you have a small tube (cannula) put into your vein in one of your arms. The doctor or nurse will take the blood samples from here.

How often you have blood tests depends on the type of surgery you have.

Surgery for cancer, or a non cancerous condition of the prostate, bladder and penis
You have a blood test

  • Before surgery
  • 30 minutes after surgery
  • 2 and 4 hours after surgery
  • 24 and 72 hours after surgery (only if you are still in hospital)

You have further blood tests on 4 different occasions over the next 6 months. You have these during your routine follow up appointments.

You have a urine test

  • Before surgery
  • Between 2 to 6 hours after surgery
  • 24 hours after surgery (only if you are still in hospital)

If you have a urinary catheter, the nurse can take a sample of urine from your catheter drainage bag. Otherwise, you are asked to collect a sample in a container.

Surgery for cancer, or a non cancerous condition of the kidney
How often and when you have your blood tests may depend on the type of kidney surgery you have.

If you have part of your kidney removed (partial nephrectomy) you have a blood test

  • Before surgery
  • 30 minutes after surgery
  • 2 and 4 hours after surgery
  • 24 and 72 hours after surgery (if you are still in hospital)

You do not have a urine test as part of this study.

Everyone
The study team will record information about your recovery and whether you have any problems following your operation. For example, they will collect information about any

  • Bleeding
  • Pain
  • Infection

The study team may also collect information about

  • Your symptoms
  • PSA blood test (for prostate conditions or cancer)
  • Results of any tests during follow up appointments

Hospital visits

You do not have any extra hospital visits as part of this study.

Side effects

There are no specific side effects associated with taking part in this study.

You may have some bruising and bleeding at the cannula site. And having a blood test can make you feel dizzy or light headed. But you would have blood tests anyway as part of your surgery, whether you take part in this study or not.

Location

Bangor
London
Rhyl
Wrexham

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Stephen Fôn Hughes
Mr Iqbal Shergill

Supported by

Institute of Biomedical Science (IBMS)
NIHR Clinical Research Network: Cancer
Betsi Cadwaladr University Health Board (BCUHB)
Health & Care Research Wales
University of Chester

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12583

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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