Current Research Studies

Principal Investigator: Dr Roshan Agarwal

The Management of Metastatic Colorectal Cancer study aims to collect international, real-world information on treatment patterns for patients with metastatic colorectal cancer. There is currently limited data available on treatment patterns particularly for drugs which are used as third-line treatment after the disease has progressed on two previous types of treatment. The study will also collect information on the safety and effectiveness of treatments, the reasons for stopping some treatments and for choosing the next treatment, the use of healthcare resources and also the effect on the patient's quality of life.

Principal Investigator: Dr Jane Parker

 

The AML18 Trial will evaluate several therapeutic questions in Acute Myleoid Leukaemia (AML). The trial will recruit 1600 patients primarily over the age of 60 who are considered fit for an intensive approach to treatment.

A randomisation will compare standard chemotherapy schedule Daunorubicin/Ara-C(DA) combined with 1 or 2 doses of Mylotarg in course 1, patients who fail to achieve CR or are MRD positive after course 1 will be randomised to compare DA with DA plus Cladribine or Flag-Ida for up to 2 courses of therapy. For patients with known adverse risk cytogenetics will enter a randomisation to compare DA versus Vosaroxin and Decitabine.

 

Patients who achieve CR after course 1 will be randomised after a further course of DA to receive either DA or IDAC in course 3. At course 2 patients will also be randomised to receive AC220 versus no AC220 with or without maintenance.

Principal Investigator: Dr Jane Parker

AML19 will build upon the results of previous trials in acute myeloid leukaemia. It will evaluate several relevant therapeutic questions in patients who are 18­60 years old and suitable for intensive chemotherapy.

 

For patients who do not have the APL subtype, the investigators will evaluate the best way of adding mylotarg to induction chemotherapy. After induction, patients will be characterised based upon their prognosis and may enter different randomisations ­ the randomisations allow patients to access different treatments based on their disease profile. The investigators will also evaluate whether continued monitoring of patients can improve outcomes and affects quality of life. Patients with the APL subtype will enter a different part of the trial.

Principal Investigator: Mrs Jane O’Callaghan

Currently, there is extremely limited information regarding the risks posed by SARS-CoV-2 virus responsible for COVID19 to patients with cancer. This study aims to understand the presentation, management and outcomes of cancer patients with COVID19. The influence of cancer type and treatment will be explored as well as comparing cancer patients with non-cancer patients.

 

This study will provide valuable information that would educate as well as help inform practice for future possible outbreaks. The information may also inform the development of guidelines with regard to the care and management of cancer patients with viruses such as COVID19 and similar infectious diseases.

Cancer is immunosuppressive, the nature of the immunosuppression seems to be influenced by the microbiota, in addition pulmonary infections are also influenced by the host microbiota, therefore it is important to understand this impact in cancer patients. Analysis of samples from cancer patients with COVID19 offer the opportunity to learn more of these interactions.

 

The purpose of CCP-CANCER UK study is to obtain additional data from patients with cancer who were/are recruited into the Principal CCP-UK study which is the key national protocol for characterising COVID19 in the UK population. This study is designed to supplement, not replace, the Principal CCP-UK protocol. 

 

This study will be open to research sites who are currently participating in the Principal CCP-UK study.  The CCP-Cancer UK study will run for two years.  An additional specific cancer data set will be collected from participant’s existing medical records. This cancer specific information when combined with the rich data set related to the COVID-19 episode (derived from CCP-UK) will enable a full understanding of COVID-19 in patients with cancer as well as enable a comparison with non-cancer patients.

Principal Investigator: Dr Sajjan Mittal

Chronic Lymphocytic Leukaemia (CLL) is the most common haematological malignancy in the UK. The most effective therapy for treating CLL is the combination of fludarabine, cyclophosphamide and rituximab (FCR). FCR is the standard therapy for patients who are fit for relatively intensive therapy however FCR is associated with significant early and late toxicity mainly with infections and bone marrow suppression.

 

As knowledge of CLL increases new therapies are being developed to treat the disease and the most promising new approach uses therapies that target signalling through the B-cell receptor (BCR) which is expressed on CLL cells and leads to CLL cell growth. Bruton's tyrosine kinase is a critical component of BCR signalling and inhibiting it by use of ibrutinib, a leading agent in the new class of therapies, leads to impressive response rates with minimal toxicity in patients with CLL who have not responded well to previous chemotherapy.

 

Ibrutinib monotherapy (I) is already widely used following phase III trials in relapsed refractory disease and has shown convincing superiority over chlorambucil in unfit or elderly patients with previously untreated CLL. It is hypothesised that the addition of venetoclax to ibrutinib will reduce MRD levels faster and more effectively than I alone or IR, and therefore improving the outcomes, allowing the duration of therapy to be reduced, leading to a reduction in long-term toxicities and an overall cost saving.

Principal Investigator: Dr Roshan Agarwal

This study is for gynaecological cancer patients who have already had their primary treatment. The most common duration of routine follow-up for these patients is 5 years. These visits evaluate how well the illness is being controlled as well as providing psychosocial support for the patient. It has been recognised that gynaecologic cancer patients experience significant levels of distress, often persisting years after completion of treatment.

 

As a result, there is disagreement as to how often these follow up visits should take place. A concern often raised is the psychological impact on patients when frequent tests are performed. The objective of this study is to identify the physical and/or psychosocial problems after treatment for gynaecological cancer. Patients will be invited to complete one set of patient-reported questionnaires when attending the hospital at one of their routine follow-up visits.

 

The questionnaires will assess the patient's quality of life as well as their satisfaction with the follow-up service that they have received. This study will take place in nhs sites in the uk as part of a wider international study.

Principal Investigator: Mr Chellappah Gnanachandran

Ovarian cancer is the leading cause of deaths from gynaecological cancers. Despite massive funding in drugs and new treatment strategies, survival rates remain poor. Only 3 in 10 women are alive at 10years. Women with a >10% risk of getting ovarian cancer are considered high-risk.

 

10% ovarian cancers are familial. The commonest cause is a fault/alteration in brca1/brca2 genes. Brca1/brca2 carriers have a 17-44% risk of developing ovarian cancer and 69-72% risk of developing breast cancer. There is currently no nhs screening programme for ovarian cancer.

 

Best current practice is to offer women at increased risk, an operation to remove their fallopian tubes and ovaries on completing their family. This significantly reduces the risk of ovarian cancer by 90% but leads to early menopause. Early menopause has serious implications including, hot flushes, sweats, mood changes and pain during intercourse. Additionally, it increases the risk of thinning of the bones, heart disease, stroke and dementia. Many women avoid/delay prevention due to this.

 

However, a significant number of ovarian cancers actually start in the fallopian tube. This has led to an attractive alternative two-stage proposal to prevent ovarian cancer. The first stage involves removing the fallopian-tubes (early-salpingectomy) alone.

 

This is followed by a second operation (delayed oophorectomy) to remove the ovaries after they have gone through the menopause. This offers protection against ovarian cancer in younger women whilst avoiding the negative health consequences of early menopause.

 

However, long term consequences of this new approach have not been adequately studied. Our uk-wide study compares old and new strategies for ovarian cancer prevention. The study evaluates the impact on sexual function, endocrine function, quality-of-life and cost-effectiveness of this new strategy in high-risk women by comparing it to the traditional strategy of removing both tubes and ovaries as well as outcomes in women who dont have an operation (controls). Women entering the study can choose whichever strategy they prefer.

Principal Investigator: Mr Chellappah Gnanachandran

Nice has issued guidelines to gps, to test women if they have certain symptoms of bloating/tummy discomfort with a blood test ca125 and then a pelvic ultrasound if the ca125 test result is abnormal. However published literature shows gps refer patients if they have symptoms or if either test is abnormal. In fact, the blood test ca125 can be raised in lots of other innocent conditions e. G. During menstrual periods. Also, in younger women, non-cancerous cysts on the ovary are very common. Conversely ca125 is only raised in half the women with early ovarian cancer. This means that many women are referred who actually have a very low risk of cancer, and others are not referred until their cancer has reached a more advanced stage.

 

By identifying better tests for ovarian cancer, we may be able to diagnose more women with ovarian cancer early but also reduce unnecessary tests, hospital visits and distress in women who dont have cancer. We also know that women with ovarian cancer who undergo thorough surgery by a gynaecological cancer specialist have the best outcomes, so improved testing in hospital after referral may also help to identify the patients who will need this.

 

Rockets study is a part of a large complex project that will first look at all the published papers on new blood tests, scan scoring and symptom scores. We will then use that information to test existing stored blood samples and data from previous large studies conducted by our collaborators, to fine-tune tests and create new scoring systems (risk prediction models) which can be used to diagnose patients by gps and after referral in hospital. We will then compare our new risk prediction model against the current prediction score (RMI) in a study of 2450 newly presenting patients with suspected ovarian cancer. This study will assess symptoms, scans and blood test results. Finally, we will use all of this information to set out best pathways for gps and hospital specialists to follow in women with suspected ovarian cancer. This ethics application is for the prospective study only.

Principal Investigator: Dr Sajjan Mittal

The UK CLL trials biobank is of pivotal importance to the NCRI CLL trials portfolio, as it allows the collection and storage of clinical samples to the highest standards across multiple trials.

In doing so, the biobank provides the UK with an unrivalled resource for high quality biomarker research which will ultimately lead to the application of stratified medicine to CLL therapy.