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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
MITRE
Study
cuh.mitre@nhs.net
Pippa
Corrie
philippa.corrie@nhs.net
Fabiana
Mariscotti
fabiana.mariscotti@nhs.net
Malignant neoplasms of respiratory and intrathoracic organsMalignant neoplasms of urinary tractMelanoma and other malignant neoplasms of skin
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
There is increasing evidence that the bacteria that live naturally in our mouth and gut (called our ‘microbiome’) influence our immune system and how it works. The mix of bacteria living in your microbiome is unique to you and this is affected by various factors, including your diet, your medications and where you live. Recently, some small studies have linked the presence of certain bacteria in a patient’s microbiome with the effectiveness of immunotherapy for cancer, particularly immune checkpoint inhibitor drugs that they have taken.
Immune checkpoint inhibitor drugs are improving outcomes for cancer patients, these drugs work by reactivating immune cells to recognise and kill cancerous cells. However, these drugs do not work for everyone and they can also cause some people side effects that are difficult to tolerate. We would like to be able to identify patients who are likely to either benefit or experience side effects from these drugs, which we cannot do currently. Previous research has mainly focussed on looking for markers in blood and tumour samples that these drugs are working or causing toxicity. We plan to undertake a detailed study of the mouth and gut bacteria of patients receiving treatment with these drugs by collecting an oral swab sample prior to treatment as well as a series of stool samples prior to and during treatment. We will collect blood samples and also tumour tissue, if it is available to us. After we analyse these samples, we hope to better understand how the microbiome contributes to the effectiveness of immune checkpoint inhibitor drugs as well as potential side effects. We hope we can use this knowledge to tailor patient treatment and potentially develop better treatments in the future.
We plan to recruit up to 1800 patients and 360 household controls over a 5 year period.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Clinical Laboratory Study;
You can take part if:
You may not be able to take part if:
CANCER PATIENT • Other invasive malignancies diagnosed within the last year which are not fully resected, or in complete remission, or for which additional therapy is required • Significant acute or chronic medical or psychiatric condition, disease, or laboratory abnormality, which in the judgment of the investigator would place the patient at undue risk, or interfere with their ability to comply with the study. Examples include, but are not limited to: o Patients with uncontrolled ischaemic heart or other cardiovascular event eg. myocardial infarction, new angina, stroke, transient ischaemic attack, or new congestive cardiac failure within the last 6 months o Presence of active infection o Cirrhotic liver disease, known chronic active or acute hepatitis B, or hepatitis C o Current active, severe, or uncontrolled autoimmune condition, including but not limited to Crohn’s disease and ulcerative colitis. • Women who are pregnant, plan to become pregnant, or are lactating during the study period • Requirement for daily non-physiological dose of oral steroids, or regular use of any other immunosuppressive agents; less than 10mg prednisolone or equivalent doses are allowed. Use of inhaled or topical steroids is allowed. HOUSEHOLD CONTROLS Confirmation of suitability to be a household control participant will be determined by completing a self-assessed questionnaire either at home or in clinic. Household controls must: • NOT have had any gastrointestinal infections i.e., parasites, viruses or diarrhoeal episodes during the last 6 months. • NOT have taken antibiotics for at least 6 months • NOT have or be recovering from any chronic intestinal disease such as: o Crohn’s disease o Ulcerative colitis o Coeliac disease o Irritable bowel syndrome o Stomach ulcers • NOT have a chronic autoimmune disease or significant allergies e.g., multiple sclerosis, asthma requiring regular medication, psoriasis. • NOT have and NOT be recovering from any form of cancer. • NOT take proton pump inhibitors, steroids, other non-steroidal anti-inflammatory drugs such as ibuprofen or aspirin. In addition, household controls must sign informed consent and be aged > = 18 years old.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Fabiana
Mariscotti
fabiana.mariscotti@nhs.net
Pippa
Corrie
philippa.corrie@nhs.net
MITRE
Study
cuh.mitre@nhs.net
The study is sponsored by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by CANCER RESEARCH UK; MICROBIOTICA LIMITED; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 43756
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