Clinical studies

ADVANTAGE

Advanced Discovery of Visceral Analgesics via Neuroimmune Targets and the Genetics of Extreme human phenotype

Chief investigator: Geoff Woods (University of Cambridge)

Co-Investigator: Andrew Horne

Trial support: Frances Collins, Priscilla Fernandez, Nicola Watson

Funder: Versus Arthritis

About this study

Looking for people at the extremes: those with little pain despite clear disease, and those with severe pain despite few signs of disease.  Diseases to be studied include: endometriosis, fibromyalgia, acute pancreatitis, polycystic kidney disease, pain associated with vaginal mesh, inflammatory bowel disease and painful bladder syndrome. 

We will record pain using standard self-report methods, but also explore other ways to capture experiences; for example, using automatic sensors to record activity and physiological changes throughout the day. To find out what causes severe pain in some people, we will study the genetic and immune systems of participants. We will also examine differences between men and women, why certain conditions predominantly affect women, and the under-representation of women in some research areas, to make sure that any new treatments benefit everyone equally.

Currently recruiting in NHS Lothian and Cambridge University Trust

Cancer, Fertility and Me

Cancer, Fertility and Me for Young Males: The development and evaluation of the first fertility preservation patient decision aid to support boys and young men with cancer. 

Chief investigator: Rod Mitchell

Trial Manager: Abi Lewis

About the study

The aim of the study is to develop and assess the acceptability of the first dedicated patient decision aid (PtDA) to better support young male cancer patients faced with a fertility preservation treatment decision before starting treatment. We will develop two versions of the PtDA, one for ages 11-15 and another for 16-25. The need, feasibility and objectives for the study were determined following our recent activities that include a systematic review of the literature and three PPI initiatives. The resources will be developed and evaluated in three stages in line with best practice methodological recommendations from IPDAS37 and consideration of other best practice decision science guidance. 

Stage 2: December 2024-April 2025 

• Group 1: Boys and young men who were previously aged 11-25 years old and faced the fertility preservation treatment decision in the past but are now at least 12 months post diagnosis,  
• Group 2: HCPs from across the multidisciplinary team who care for and manage boys and young men diagnosed with cancer 
• Group 3:  Key stakeholders e.g. schools, charities and other interested groups 

Stage 3: July 25- February 2026 

• Boys and young men referred with a new diagnosis of cancer to key sites in Leeds. Sheffield and Edinburgh 
• Aged between 11-25 
• About to start gonadotoxic therapy and considering fertility preservation  

Currently recruiting

Cryopreservation of testicular tissue study

Cryopreservation of pre- and peri-pubertal testicular tissue for preservation of fertility in young boys with cancer

Chief Investigator: Rod Mitchell

Lothian Principal Investigator: Rod Mitchell

Research Support: Michaela Rodger

Funder: Children with Cancer charity

About the research

Our research group interests include fertility preservation in children with cancer and this focuses on developing strategies for removing and storing testis tissue from patients prior to potentially sterilizing treatments in order that germ cell development can be achieved using in-vitro or in-vivo techniques. There are 49 patients with tissue frozen.

Currently recruiting across the UK

EdUMEd

Edinburgh: Improving understanding and management of endometriosis 

Chief Investigator: Andrew Horne

Trial Manager: Ann Doust

About the study

We aim to collect data and biological specimens to enhance the understanding of endometriosis and inform the development of better diagnostic and treatment options. Additionally, we aim to give patients the option of longer-term follow-up to investigate the factors influencing disease prognosis in people with endometriosis. Furthermore, we aim to gather data and biological specimens from people with suspected-endometriosis who have no pathology identified at the time of surgery to enhance the understanding of chronic pelvic pain and inform the development of better diagnostic and treatment options for this additional cohort. We will include women and transgender men.

Currently recruiting in NHS Lothian

ENDOCAN-1

A pilot randomised controlled trial of the efficacy of a cannabinoid oral tincture in the management of endometriosis-associated pain (2023-2026)

Chief Investigator: Lucy Whitaker

Lothian Principal Investigator: Lucy Whitaker

Trial Manager: Frances Collins

Funder: CSO

About the study

We are studying a drug called cannabidiol (CBD) to see if it helps with endometriosis pain. Endometriosis is a condition where tissue, like the lining of the uterus, grows outside of it. This often causes pain. We want to find out if CBD can help reduce this pain. 

Why are we studying this? Endometriosis is associated with inflammation. Cannabinoids are substances extracted from cannabis and are promising treatments for pain conditions. In laboratory models of endometriosis cannabinoids reduce inflammation and can shrink endometriosis deposits. We know that many patients use cannabinoids but so far there have not been any clinical trials to determine if this an effective treatment for endometriosis, or what the right dose is. There are lots of different types of cannabinoids and the two most studied cannabinoids are THC and CBD. THC is the part that makes you feel high, while CBD doesn’t cause intoxication and has fewer side effects. A very similar CBD-based medicine called Epidyolex is approved to treat types of epilepsy in children. 

What is this new trial? This trial (called ENDOCAN-1) will help us to find out what might be the best dose of a CBD medication (called MRX-1) to reduce pain and causes the fewest side effects. We also want to know if we have the correct trial design which makes it easy for people to take part in such a study. This will help us plan a bigger clinical trial in the future to see if CBD is an effective and acceptable treatment for endometriosis.

Due to start recruitment in August 2025 in NHS Lothian and NHS Grampian.

EndoFLARE

Improving understanding of endometriosis pain flares to support patients with self-management and prevention (EndoFLARE): a feasibility study (2023-2024)

Chief Investigator: Lucy Whitaker

Lothian Principal Investigator: Lucy Whitaker

Research Support: Frances Collins and Jane Hellewell

Funder: Academy of Medical Sciences

About the study

In this study we aim to recruit 10-15 individuals who experience pain flares due to endometriosis, and monitor them for 12 weeks. During this time we will ask them to complete online questionnaires, wear a smartwatch and collect different types of samples (including blood, stool, urine and saliva). Some samples will be collected at a hospital visit, but most will be ‘self-collected’ at home and posted back to the research team.

Recruitment is now finished. Results will be published in 2025.

ENDO1000

This is a UK-wide research project that will collect data and biological samples from 1000 individuals with endometriosis. The resulting resource will allow much needed research into the development of personalised care for people with endometriosis.

EPiC2

A randomised, double-blind, placebo-controlled feasibility trial to evaluate dichloroacetate in the management of endometriosis-associated pain (2023-2026)

Chief Investigator: Lucy Whitaker

Lothian Principal Investigator: Lucy Whitaker

Research support: Lauren Sutherland

Funder: Wellbeing of Women

About the study

We are studying a drug called dichloroacetate (DCA) to see if it helps with endometriosis pain. Endometriosis is a condition where tissue, like the lining of the uterus, grows outside of it. This often causes pain. We want to find out if DCA can help reduce this pain.

Why are we studying this? In people with endometriosis, there is often more lactate in their pelvis. Lactate is made by cells when they turn food into energy. We think that too much lactate might cause endometriosis to get worse and lead to more pain.

DCA is already used to lower lactate in other conditions, like in children with certain metabolic problems. We have done a small study (called EPiC1) with DCA and think it has promise to treat endometriosis. However, no large studies have been done to see if DCA can help with endometriosis.

What is this new trial? This new trial (called EPiC2) will help us find out the best dose of DCA that reduces pain and causes the fewest side effects. This will help us design a bigger study in the future to see if DCA is an effective treatment for endometriosis.

Due to start recruitment in Spring 2025 in NHS Lothian and West Middlesex Hospital.

ESPriT2

A multi-centre randomised controlled trial to determine the effectiveness of laparoscopic treatment of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (2021-2026)

Co-Chief Investigators: Andrew Horne and Lucy Whitaker

Lothian Principal Investigator: Lucy Whitaker

Research Support: Lauren Sutherland, Priscilla Fernandez and Ann Doust

Funder: NIHR (HTA)

Recruitment ends 31st December 2024.  If you would like to take part in ESPriT2, please look to see if you are being cared for by one of our recruiting centres. If you are, then please talk to your care team to see if you can take part. More information can be found on the ESPriT2 website.

IMAGEN

The Impact of Androgens on Endometrial Health

Chief Investigator: Jackie Maybin

Lothian Principal Investigator: Jackie Maybin 

Research Support: Laura Edwards

Funder: Wellcome Trust

About the study

The aim of this study is to determine the impact of androgen medications on the lining of the womb (e.g. in those undergoing gender reassignment). This study is recruiting people who are having a hysterectomy who are taking androgens and those who are not (controls). Participants will be asked to provide a blood sample and a sample of the womb at the time of their hysterectomy. It does not alter the surgical procedure.

Currently recruiting in NHS Lothian

IMMENSE

Developing a better understanding of menstruation (periods) in those with endometriosis

Chief Investigator: Andrew Horne

Lothian Principal Investigator: Priscilla Fernandez

Research Support: Rebecca Ainslie and Ann Doust

About the study

There is an unmet need to better understand the impact of aberrant menstruation on endometriosis pathogenesis in order to identify specific pathways that could be altered in endometriosis. We aim to collect data and biological specimens to enhance the understanding of the regulation of menstruation in endometriosis. Identification of functional differences in the menstruation may allow for identification of novel targets for treatment of endometriosis.

 Recruitment: Due to start February 2025

INFLO

Information from Menstrual Fluid

Chief Investigator: Jackie Maybin

Lothian Principal Investigator: Jackie Maybin 

Research Support: Marianne Watters and Laura Edwards

Funder: Wellbeing of Women

About The Research

This study aims to determine whether menstrual fluid can be used to confirm heavy periods and underlying causes. Participants will be asked to provide a menstrual fluid sample (using a menstrual cup) and to collect all products (tampons/pads) used across one episode of menstruation. Participants will also be required to provide a venous blood sample. Participants also have the option of providing a sample of the lining of their womb (endometrial biopsy) at the time of menstruation. In addition, participants also have the option of collecting a vaginal swab and stool sample before and after their period for assessment of the microbiome and how this may influence menstrual bleeding.

Recruitment: Currently recruiting in NHS Lothian and surrounding areas

MAC-Endo 

A proof-of-concept and feasibility study of macrophage-targeted immunotherapy in the management of endometriosis-associated pain (2024-2026)

Chief Investigator: Andrew Horne

Lothian Principal Investigator: Andrew Horne

Research support: Ann Doust and Wellcome Trust Clinical Research Facility

Funder: CSO

About the study

We plan to perform a study, called MAC-Endo, of 36 women with endometriosis. In this study, we will recruit patients with endometriosis to investigate the safety and side-effects of a drug called RRx-001. RRx-001 is an immune therapy designed to modify macrophages in cancer, and we plan to see if this drug may be useful in treating symptoms of endometriosis, as there are some similar characteristics between endometriosis and cancer. We will collect data in this study to assess the feasibility of a future large-scale UK-wide trial, to determine whether RRx-001 can reduce endometriosis-associated pain.

Participants will be randomly assigned to receive once-weekly RRx-001 or identical placebo, for six weeks. Participants will complete questionnaires about their symptoms, give blood samples and have samples taken of their womb-lining. We will interview  women who agree to this, at the end of their participation, to find out their feelings, views, and thoughts about all aspects of the trial. The information derived from the questionnaires, analysis of the blood and womb-lining samples and the interviews will help us plan a future larger study to determine whether RRx-001 reduces endometriosis pain. 

Due to start recruitment in February 2025 in NHS Lothian.

MEWS

MicrosatEllite Womb Surveillance (MEWS) study 

Chief Investigator: Neil Ryan

Lothian Principal Investigator: Neil Ryan

Research Support: Ann Doust and Cathy Wells

Funder: Academy of Medical Science

About the study

At the moment, women (and those female at birth) with a high risk of developing cancer of the womb (those with Lynch syndrome) have to undergo testing every year. This is by a camera being placed inside the womb and a biopsy taken (sample of the womb lining). This is a painful test and means that some do not want to go through this every year. We would like to see if we can develop a test on a urine sample to see if we can detect this cancer. In order to do this, we need to get urine samples from people with womb cancer and those who do not have cancer but are at a higher risk, those with Lynch syndrome. We will then compare the two sets of samples and see if we have a reliable test to use for diagnosing this cancer.

N.B. For this study, when we refer to women, this includes those assigned female at birth.

Currently recruiting in NHS Lothian

PETAHG

Performance of tampons as a biospecimen collection tool for the detection of Human Papillomavirus in a colposcopy setting

Principal Investigator: Dr Kate Cuschieri

Research Nurse: Sharon McPherson

Funder: Daye Ltd 

About the study

Women attending routine colposcopy clinics as part of standard care will be provided with the opportunity to participate in this study looking at a new way of sampling for Human Papillomavirus (HPV) detection using tampons – self sampling. 

A study pack containing tampons, instructions for use, transport medium liquid and packaging for the tampon will be posted out to interested patients. On the day of the planned Colposcopy appointment, we ask them to insert the tampon (in the privacy of their own home) and after a specified time remove tampon and package up in bags provided to bring to clinic. 

They are then seen for the scheduled clinical appointment by the healthcare specialist, who, in addition to performing a colposcopy examination, will also take a smear sample for this study.

We aim to evaluate the clinical performance of the DAYE Diagnostic Tampon (DDT) for the detection of HPV infections associated with clinically significant cervical disease, compared to a clinician taken sample.

The study could help future generations of women as it will provide more information on self-testing that will enable individuals to collect a sample in the privacy of their homes.

Currently recruiting in NHS Lothian

For more information contact Dr Cuschieri (0131-242-6039) or Sharon McPherson (0131-242-2483)

PET-Endo

Novel non-invasive imaging of endometriosis using total-body PET-CT Programme 

Trial Manager and Chief Investigator: Lucy Whitaker

Funder: MRC

About the study

In this study we are going to use two different radiotracers which we believe may be helpful for identifying endometriosis. One is called GP-1 which identifies blood clots and the other is called FAPI, which identifies cells which form scar tissue. Both blood clots and scarring are involved in endometriosis lesions. This is because the cells within endometriosis lesions respond to hormones in the same way as endometrium during the menstrual cycle, with repeated episodes of inflammation and bleeding. Overtime, the endometriosis lesions develop scarring (fibrosis). We wish to see if the two radiotracers are taken up by endometriosis lesions and can be seen on total-body PET-CT and PET-MRI, and if the stage of the menstrual cycle affects the amount of radiotracer in endometriosis lesions.

Recruitment due to start in spring 2025

REGAL

Recurrence of Endometriosis: A randomised controlled trial of clinical and cost-effectiveness of Gonadotrophin Releasing Hormone Analogues with add-back hormone replacement therapy versus repeat Laparoscopic surgery

Chief investigator: Lucky Saraswat

Co-investigator: Andrew Horne 

Principal Investigator: Lucy Whitaker

Research support: Jane Hellewell, Aberdeen Clinical Trials Unit (ChART)

Funder: NIHR (HTA)

About the study

Endometriosis is diagnosed by laparoscopy (keyhole surgery) which identifies areas of endometriosis which can then be destroyed or removed. However, surgery rarely provides lasting relief and pain can return in up to half of treated women within five years. To reduce the chance of regrowth of endometriosis and recurrence of pain, women who are not trying to get pregnant are offered the combined oral contraceptive pill or other contraceptives containing hormones called progestogens. Despite this, about one in three women will require more operations to treat endometriosis that has come back. 

A less invasive way of shrinking endometriosis is to use a drug called Gonadotrophin Releasing hormone analogue (GnRHa) which temporarily stops the ovaries from producing oestrogen. While very effective in terms of reducing pain, this treatment has only been used for up to a year because of side effects such as hot flushes and night sweats and concerns about osteoporosis (thinning of the bones). Recent research has shown that adding small doses of hormone replacement therapy (HRT) in women on GNRHa reduces the risk of side effects and osteoporosis whilst controlling the pain. 

REGAL trial is comparing long-term GnRHa with added HRT to further keyhole surgery for treatment of endometriosis in women who experience recurrence of pain after surgery but wish to preserve their fertility. 

Currently recruiting in NHS Lothian and across the UK

STOPPIT-3

A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins

Chief Investigator: Sarah Murray

Lothian Principal Investigator: Sarah Murray

Research Support: Edinburgh Clinical Trials Unit, Denise Cranley 

Funder: NIHR

About the study

This trial aims to find out if medicines called antenatal corticosteroids (ACS) given to women with a twin pregnancy prior to a planned birth of twins after 35 weeks of pregnancy reduces breathing difficulties in the twin babies.

This trial is organised and sponsored by the University of Edinburgh and NHS Lothian. It will run in NHS centres throughout the UK and we will need around 1,550 women to take part in the trial to be able to see how ACS works in twins.

Women who attend a hospital running the trial and fit the eligibility criteria below may be approached by their clinical team to participate. The women’s obstetrician or a member of the midwifery team will discuss the trial with the women and decide if they can and want to take part. 

Currently recruiting in Lothian and in selected sites across the UK.

STOPPIT-M

STOPPIT-M is linked to the main STOPPIT-3 trial. This study will only be recruiting women pregnant with twins with a planned caesarean birth scheduled between 35+0 and 38+6 weeks gestation enrolled in the STOPPIT-3 trial.

Chief Investigator: Sarah Murray

Lothian Principal Investigator: Sarah Murray

Research Support: Edinburgh Clinical Trials Unit, Denise Cranley 

Funder: NIHR

About the study

In this study, we will aim to explore how antenatal corticosteroids (ACS) work and why responses to ACS vary between babies. The main trial STOPPIT-3 aims to resolve uncertainty about whether ACS given to women with a twin pregnancy reduces breathing complications in twin babies.

In STOPPIT-M, we want to understand why ACS work for some babies, but other babies still develop problems. We know that ACS can directly cross the placenta and reach the baby. We think that ACS may “damp down” the babies own ‘stress response’ systems and that this may be the reason why some babies have problems such as breathing difficulties and low blood sugar levels.

Currently recruiting in Lothian and in selected sites across the UK.