Current and ongoing studies

You can find out details below of our current and ongoing studies.

Cancer

Bridging the age gap in breast cancer: improving outcomes for older women

If you are 70 years or older with breast cancer you could be eligible to take part in bridging the age gap study.

The study is looking at finding ways to improve treatment outcomes for older women with breast cancer and also develop a tool to help older women and their doctors make decisions about breast cancer treatment.

For more information please contact Helen Wilson 01642 383277.

UK genetic prostate cancer study

The study aims to recruit 26,000 men to discover why prostate cancer develops, particularly in young men, and in men with a family history. We also hope it will help us to understand the cause of the disease in patients who do not necessarily have a family history.

If you were diagnosed with prostate cancer at 60 years or under or have a strong family history of the disease you may be eligible to take part.

For more information please contact Helen Wilson 01642 383277

For information on other cancer clinical trials please visit the Cancer Research UK website http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial

Women’s health

HEALTH

Are you less than 50 years of age and having problems with heavy menstrual bleeding? If you have no plans to conceive and your doctor considers surgical intervention is appropriate then you may be eligible for the HEALTH study.

This clinical trial is comparing clinical and cost effectiveness of laparoscopic supra-cervical hysterectomy (LASH) with endometrial ablation (EA) in women with heavy menstrual bleeding (HMB).

We are recruiting into this study until February 2016. Please contact research midwife Anne-Marie Jones anne.jones@nth.nhs.uk  or 01642 383111 if you have any queries or would like to take part.

VUE

Are you experiencing the discomfort and functional symptoms of pelvic organ prolapse (uterus and/or vaginal prolapse)?

If so you may be eligible for this study which is exploring optimal surgical management for women with pelvic organ prolapse.

Two parallel trials will compare options as follows:

Uterine trial: In women having uterine prolapse surgery, the effects of removal of the uterus versus uterine preservation.

Vault trial: In women having vault prolapse surgery, the effects of a vaginal vault suspension versus an abdominal vault suspension.

We are recruiting into this study until August 2016. Please contact research midwife Anne-Marie Jones anne.jones@nth.nhs.uk or 01642 383111 if you have any queries or would like to take part.

PRE-EMPT

Are you a woman experiencing chronic pelvic pain? Has your doctor suggested the possibility that endometriosis may be the cause?

If so you may be eligible to take part in this clinical trial which is looking at the prevention of the recurrence of endometriosis by means of long acting progestogen therapy – either a combined oral contraceptive, a three monthly progestogen injection or an intra-uterine system (coil).

We are starting recruitment into this study in October 2015. Please contact research midwife Anne-Marie Jones anne.jones@nth.nhs.uk or 01642 383111 if you have any queries or would like to take part.

Neonatal

BABY-OSCAR (outcome after selective early closure of patent ductus arteriosus (PDA) in preterm infants)

This trial is open to premature infants born at <29 weeks gestation, 72 hours of age and with a PDA of >1.5mls (confirmed by echocardiography examination).

The trial is recruiting around 750 babies in total from across the UK. The aim of the trial is to determine if preterm babies born with large PDA should be treated with ibuprofen or not within the first 72 hours.

For further information please contact professor Samir Gupta, chief investigator on 01642 624250 or samir.gupta@nth.nhs.uk

ELFIN

A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants.

Infants born at <32 weeks and/or <1500g birth weight would be eligible to take part in this national study which is recruiting 2,200 patients.

The trial is looking at whether providing a daily supplement of lactoferrin to very preterm infants prevents late-onset (after 72 hours of age) invasive infections and necrotising enterocolitis (NEC), which are leading causes of death and disability in premature infants.

For further information please contact Dr Sundaram Janakiraman, principal investigator on 01642 624250 or  sundaram.janakiraman@nth.nhs.uk

PlaNet 2 – Platelets for neonatal transfusion – study 2

The effectiveness and safety of thresholds currently used for transfusing platelets in preterm neonates has not been established in randomised controlled trials. Platelets are the cells that help the blood to clot.

Platelet counts sometimes fall to low levels in about 5% (1 in 20) of babies on the neonatal unit, usually when babies are unwell. Platelet transfusions are like blood transfusions only the bag contains platelets and no red blood cells.

Platelet transfusions are given to babies with low platelets and signs of bleeding, but we do not know when best to give platelet transfusions to babies with low platelets and no signs of bleeding.

The aim of this study is to understand better when to give transfusions of platelets to babies with low platelet counts. Approximately 700 babies will be taking part and the trial is open to babies born <34 weeks gestation with a platelet count below 50.

For further information please contact Dr C Harikumar, principal investigator on 01642 624250 or chidambara.harikumar@nth.nhs.uk

Stroke

TICH-2

The aim of this study is to assess whether tranexamic acid reduces death and dependency after a bleed in the brain. It is recruiting 200 participants into this trial

You may be eligible for this trial if:

  • 18 years and older
  • Spontaneous bleed with no head trauma
  • You are within eight hours of onset of symptoms

For further details, please contact stroke research nurse, Susan Crawford, on 01642 383706.

RESTART

The aim of the study is to assess whether it is safe to restart antiplatelet therapy on patients who have had a bleed in the brain. The trial is aiming to recruit 720 participants in total.

You may be eligible for this trial if:

  • 18 years and older
  • Spontaneous bleed without head trauma
  • More than 24 hours past onset of symptoms

For further details, please contact stroke research nurse, Susan Crawford, on 01642 383706.

Respiratory

PASIC – Pharmacogenetics of adrenal suppression with inhaled steroids in COPD

  • Do you have COPD but no other respiratory condition?
  • Are you using a steroid inhaler?

You may be eligible to take part in a study to determine how well the adrenal gland is working and to determine if using a steroid inhaler suppresses its function or not.

The benefit of this study will be that it will help to guide doctors on what dose of steroid inhalers to use in patients with COPD so that we can minimize adrenal suppression.

For more information, please contact the respiratory research nurses on 01642 624580.

TWICS – Effectiveness of low dose oral theophylline as an adjunct to preventing exacerbations of COPD

This study tests recent laboratory work that shows that low doses of theophyilline make steroid inhalers work better in people with COPD (theophyilline will not reduce how well your existing medication works).

You may be eligible for this study if;

  • You have COPD
  • Have had two or more flare ups of your COPD in the past 12 months
  • You use a steroid inhaler

For more information, please contact the respiratory research nurses on 01642 624580.

Dermatology

Do you suffer with psoriasis?

Psoriasis is a skin condition that can impact on patient’s quality of life. First line treatment for psoriasis is not always effective. Patients commencing on biological treatments or established treatment such as acitretin, methotrexate, fumaric acid, ciclosporin could be eligible to take part in dermatology research.

The purpose of this research study is to assess whether the new biological treatments used in the treatment of psoriasis have any side effects when used long- term in real life not revealed during shorter-term clinical trials.

These side effects, if any, will be compared to those seen with the established treatments. The study therefore involves following up patients taking a number of different drugs for psoriasis and assessing the frequency that long-term side effects occur.

For more information contact Sue Kelsey on 01642 383116.

Diabetes

ADDRESS-2

Address-2 has funding from Diabetes UK and the Juvenile Diabetes Research Foundation. The purpose of the research is to identify people newly diagnosed with type 1 diabetes who may be interested in taking part in research.

We want to understand more about the development and progression of type 1 diabetes, new treatments, how diabetes is managed, and diabetes education and to investigate further what causes type 1 diabetes.

For more information contact Sue Kelsey on 01642 383116.

TrialNet

TrialNet screens relatives of people with type 1 diabetes. They have about 15 times greater risk for developing the disease than people with no family history.

We can screen you for the national history study if you are:

  • 3 to 45 years old and have a brother, sister child, or parent with type 1 diabetes. or
  • 3 to 20 years old and have a cousin, aunt, uncle, niece, nephew, half-brother, half-sister, or grandparent with type 1 diabetes.

For more information contact Sue Kelsey on 01642 383116.