ADD-ASPIRIN

Miss Sunita Shrotia (Consultant Breast Surgeon)

Add-Aspirin is a large randomised clinical trial, which is taking place in the UK and India. It will recruit 11,000 participants to help find out whether regular aspirin use after treatment for patients with early stage colorectal, breast, prostate and gastrointestinal cancers can prevent the cancer from coming back and preventing deaths. Aspirin is a common painkiller drug that doctors use to prevent heart attacks and stroke in some people. The results of research into using aspirin to prevent heart attacks or strokes has suggested that people who take aspirin regularly are less likely to develop cancer and if they do it is less likely to spread.
ALCOHOL (in follow-up)

Dr Clare Smith (Consultant Palliative doctor)

People with advanced cancer have lots of difficult issues to deal with which has a significant emotional impact and caring for a loved one with cancer can also be very difficult. Alcohol can be used to cope with stress, however it is unclear how common alcohol problems are in people with cancer and their psychological problems or carer burden. This is a unique study and would enable developed strategies to target and improve quality of life in these groups as people with cancer and caregivers are often overlooked in terms of assessing and targeting strategies to help with alcohol problems.
ARISTOTLE (in follow-up)

Dr Sharadah Essapen (Consultant Colorectal Oncologist)

This is a two-arm phase III multicentre randomised controlled interventional trial. Some patients with rectal cancer benefit from receiving chemotherapy and radiotherapy before they have an operation to remove their cancers. This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer.
Asy Ms-Meso (in follow-up)

Dr Paul Murray (Consultant Respiratory Doctor)

The aim of this study is to develop a mobile phone system to help in the reporting and management of symptoms experienced by people with mesothelioma (phase 1). The study also aims to find out how useful and acceptable people with mesothelioma, health professionals and their carers find the mobile phone system for the reporting and management of their symptoms (phase 2). The results of the study will tell us if the use of mobile phones to report and manage symptoms is feasible and acceptable to people with mesothelioma and those caring for them. This information may be used to inform larger research studies to determine whether this type of technology should be used routinely in patient care.
CADMUS

Mr Nimalan Arumainayagam (Consultant Urologist)

The CADMUS trial is for patients that may need a prostate biopsy. The common practice in this situation is to have an MRI scan beforehand. If the MRI scan shows areas of concern then these areas are biopsied to take small tissue samples to get a diagnosis. This study is looking at whether a new type of imaging test, called multi-parametric ultrasound, can detect prostate cancer as accurately as MRI by comparing it with both MRI (the scan most commonly used at the moment to look at prostate cancer) and also the results of your prostate biopsy. The study uses a much more advanced type of ultrasound than usual. This is called multi-parametric ultrasound and can collect more information from the prostate in hope to gather similar information about the prostate as with an MRI scan. This may allow in the future finding out whether or not a man has prostate cancer without the need for an MRI.
CIPHER

Mr Philip Bearn (Consultant Colorectal Surgeon)

Around 20,000 people each year have an operation to form a stoma. This is a procedure to divert faeces away from the gastro-intestinal tract (bowel) and is usually required if the bowel becomes damaged either by injury or disease. Most patients who have this operation have a good recovery and are able to manage their stoma well. However, a small number of patients develop a complication called a parastomal hernia (PSH). This is a bulge that develops under or near the stoma, which is caused by weakening of the muscles in the tummy. Unfortunately, we do not know why some patients develop a parastomal hernia and others do not but we think it may be related to how the stoma is formed. This research aims to find out which surgical factors are linked with parastomal hernias by simply collecting details about a patient’s surgery and recovery to better understand why some patients develop parastomal hernias and others do not. This information will be very useful to the NHS and future patients.
MACPT Trial

Susan Dargan

This trial assesses ‘Managing Advanced Cancer Pain Together’ (MACPT) tool to facilitate communication of total cancer pain between advanced cancer patients and their healthcare professionals during a face to face consultation. The communication tool has been developed for use in clinical practice with people living with advanced cancer (lung, breast, prostate and multiple myeloma) – and aims to try and employ a more patient centred approach towards treatment decision-making, using a series questionnaires, which is increasingly recognized as important throughout healthcare.
NeoART

Mr Pasha Nisar (Consultant Colorectal Surgeon)

The NeoART trial is for patients with bowel cancers that has not spread to other organs and who are waiting for an operation to remove their cancer. The aim is to determine whether taking a 2 week course of oral Artesunate 200mg daily prior to surgery can improve survival rates and reduce the risk of the cancer coming back after surgery by comparing two groups of patients: those who take the Artesunate with those who took a matching placebo (dummy pill). Artemisinins like Artesunate are used worldwide as part of the treatment for malaria. They come from a plant called sweet wormwood and have been used in traditional Chinese medicines. A small pilot feasibility study in 20 patients conducted at St Georges Hospital in London showed that pre-operative Artesunate was well tolerated. There were also fewer cancer recurrences in the group assigned to Artesunate treatment compared with the placebo.
NSCCG

Mr Johnathan Trickett (Consultant Colorectal Surgeon)

The purpose of the National Study of Colorectal Cancer Genetics is to collect information such as bloods from individuals who have been diagnosed with colorectal cancer who also have a family history of the condition, so that we can try and identify new hereditary factors (genes) that may lead to the development of colorectal cancer and further increase our understanding of why this condition develops and perhaps provide new targets for chemotherapy.
PERSEPHONE (in follow-up)

Dr May Teoh (Consultant Oncologist)

We invite you to take part in this trial because you have recently been diagnosed with breast cancer which has high levels of HER-2. This is called HER-2 positive breast cancer. HER-2 occurs on the surface of some cells and makes the cells divide and then grow. Trastuzumab (Herceptin®) is a protein treatment (monoclonal antibody) which blocks the normal action of HER-2, and can help reduce the risk of cancer returning. Persephone is an academic trial which aims to establish what is the best length of trastuzumab treatment for patients with Her2+ breast cancer. The optimum trastuzumab duration has not yet been determined as when the drug was first manufactured there was no obvious scientific argument for administering it for 12 months. A large international trial has recently shown no difference in benefit between 12 and 24 months so more isn’t necessarily better. Researchers in another large trial have failed to show that 12 months is better than 6 months. Further analyses are on-going and, although 12 months remains the current standard of treatment, it may well be that the benefit comes from the first 6 months of trastuzumab. The purpose of the PERSEPHONE trial is to confirm whether shorter treatment with trastuzumab for 6 months is as clinically effective and better tolerated than 12 months.
POSNOC

Mr Manish Kothari (Consultant Breast Surgeon)

This trial is looking at treatment to the armpit after surgery to remove early stage breast cancer. The trial is for women whose breast cancer has spread to 1 or 2 lymph nodes. If the cancer has started to spread, patients will have to have chemotherapy, hormone therapy or both. Currently patients will also have treatment to the lymph nodes in the armpit which could involve more surgery or radiotherapy to the lymph nodes. But it isn’t clear if having treatment to the lymph nodes is useful or necessary as drug treatments are more advanced and very good at preventing the cancer from coming back. Researchers want to compare women who have treatment to the lymph nodes in their armpit with women who don’t.
PQIP

Mr Mark Macgregor (Consultant Anaesthetist)

The NHS is committed to improving the quality of patient care. However, we know that standards and outcomes can vary between organisations – which means that while some providers may be struggling to deliver best care, others are achieving great results, and we can all learn from how they do this. The Perioperative Quality Improvement Programme (PQIP) is a novel system which will measure and improve patient outcomes after major surgery. Using an innovative but evidence-based approach, we will support clinicians in delivering high quality perioperative care, through the use of data and shared learning.
Profile

Mr Nimalan Arumainayagam (Consultant Urologist)

This study is looking at the role of gene changes in screening for prostate cancer. It is for men aged 40 to 69 who are of Caucasian (European, North African or Middle Eastern) or who are of black African Caribbean descent and who have a family history of prostate cancer. The study follows the pilot study which looked at the DN and results from prostate cancer screening tests of men with a family history of prostate cancer. Men taking part will have prostate cancer screening tests such as scans, some prostate tissue samples taken (a biopsy) as well as blood and urine tests. From these results of these tests researchers will build a genetic picture of each man’s gene changes and also look for other biomarkers for prostate cancer.
PRONOUNCE

Mr Nimalan Arumainayagam (Consultant Urologist)

The primary objective is to assess the effect of a gonadotropin-releasing hormone (GnRH) receptor antagonist (degarelix) on the risk of occurrence of major adverse cardiovascular events (MACEs) (a composite of death due to any cause, non-fatal myocardial infarction or non-fatal stroke) as compared to a GnRH receptor agonist (leuprolide) in patients with prostate cancer and concomitant cardiovascular disease (CVD). To assess the rate of specific MACEs (individual components of the composite MACE endpoint), i.e. myocardial infarction (fatal, non-fatal) or stroke (fatal, non-fatal), in patients randomized to degarelix versus leuprolide.
PHOTO (in follow-up)

Mr Sachin Agrawal (Consultant Urologist)

For some people, early (non-muscle invasive) bladder cancer comes back after it is first treated. Initial treatment for early bladder cancer involves surgery to remove the cancer (transurethral resection of a bladder tumour (TURBT). This surgery is done using a telescope put into the bladder through the urethra (cystoscopy). Surgery is normally done using a white light to allow your surgeon to see the cancer and remove it. There is an option to use blue light during surgery instead. If this is used after a liquid has been applied to the inside of the bladder, it may help your surgeon see more of the cancer and to remove it more effectively. It is not known if this blue light approach is better than the standard white light surgery and this is the focus of the study.
PUrE

Mr Sachin Agrawal (Consultant Urologist)

PUrE is a research study collecting information on the different ways of treating lower pole kidney stones. PUrE stands for the Percutaneous nephrolithotomy, flexible Ureterorenoscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone. Kidney stone disease is very common (around 10% of adults will suffer in their lifetime) and mainly affects adults of working age (18 – 55 years). Over a quarter of patients with stones will require treatment and about half of all patients will go on to develop another stone. Although some stones do not cause any problems, patients can develop serious symptoms including pain, infection, bloody urine and their kidneys can stop working as well as normal. Currently within the NHS there are three treatment options for treating these stones depending on their size: extracorporeal shockwave lithotripsy; percutaneous nephrolithotomy and flexible ureterorenoscopy with laser lithotripsy. At the moment there is no clear evidence of what is best as reported by patients and in costs to the NHS and the aim of the PUrE study is to answer these questions.
SUBSONIC

Mr Pasha Nisar and Mr Gregory Thomas (Consultant Colorectal Surgeons)

Faecal incontinence (FI) is when you do not have control over defecation. A relatively new treatment called sacral neuromodulation (SNM) is now commonly offered to adults suffering with FI. Suitable patients include those with faecal incontinence caused by childbirth, surgery, and advancing age. A battery powered unit is implanted into the lower back. This is connected to electrodes which rest on the nerves in the lower spine. This stimulator then continuously sends electrical impulses to the nerves and muscles that control the lower bowel (rectum and anus). The result is improved continence. Previous studies have reported a great benefit of SNM in some patients. Unfortunately, other patients can have little or no response. We are still unsure about how SNM restores bowel control, and we still do not know with certainty how effective SNM really is. SNM costs on average £10,000 per patient just for the equipment and is not without its risks and side-effects. It is therefore vital that these questions are answered. The aim of this study is to establish how SNM works and how well SNM works. These specialist tests will study their anal and rectal function as well as their corresponding brain activity.
TRACER- X

Dr Muthuveni Ezhil (Consultant Clinical Oncologist)

The TRACERx (TRAcking Cancer Evolution through therapy (Rx)) lung study is a multi-million pound research project taking place over nine years, which will transform our understanding of non-small cell lung cancer (NSCLC) and take a practical step towards an era of precision medicine. In addition, it will use a whole suite of cutting edge analytical techniques on these patients’ tumour samples, giving unprecedented insight into the genomic landscape of primary and metastatic tumours and the impact of treatment upon this landscape. The primary objectives will define the relationship between intratumor heterogeneity and clinical outcomes following surgery and adjuvant therapy as well as establish the impact of adjuvant platinum-containing regimens upon intratumor heterogeneity in relapsed disease compared to primary resected tumour.
UKGPC

Catherine Gray (Research Nurse)

This study is trying to find out more about how family history can increase a man’s risk of prostate cancer. Previous research has suggested that if a man has a family history of prostate cancer this will increase the risk of developing this disease. This study aims to increase our understanding of the genetic causes of prostate cancer and in the long-term help to find ways to diagnose prostate cancer early and to prevent prostate cancer in some men.
Vascular project

Catherine Gray (Research Nurse)

This project is looking into different ways in which services for vascular disease could be provided in the UK by finding out the views of the general public by using telephone interviews lasting between 20-30 minutes. Vascular services are health care treatments for people who have vascular disease such as problems with their blood circulation system. Examples of vascular disease include varicose veins, venous leg ulcers, peripheral arterial disease, carotid arterial disease (which can lead to strokes), and aortic aneurysms. The results of the study will be used to make recommendations about how vascular services could be better organised to produce the most benefit for patients.

 

Trials in follow-up are not currently recruiting.