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Spots Global Cancer Trial Database for Microbiome Immunotherapy Toxicity and Response Evaluation

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Trial Identification

Brief Title: Microbiome Immunotherapy Toxicity and Response Evaluation

Official Title: An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and Toxicity in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy

Study ID: NCT04107168

Study Description

Brief Summary: This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer.

Detailed Description: The gastrointestinal microbiome of a healthy individual is comprised of many hundreds of bacteria species and thousands of bacteria strains. The composition of bacteria in an individual's microbiome can change over time and this can be influenced by factors including diet, drugs, genetics and infection. These bacteria play a central role in digestion of food, development and regulation of our immune system as well as our resistance to pathogens. Recent evidence suggest that a patient's intestinal microbiota composition plays a critical, though as yet poorly defined, role in determining both therapeutic efficacy and likelihood of significant adverse events to T-cell checkpoint inhibitor immunotherapy. Immune checkpoint inhibitors are revolutionising treatment of many types of metastatic cancer, including melanoma, renal and non-small cell lung cancer, in the expectation of improving patient overall survival. However, they have limitations as they do not work for all patients and can cause unpredictable, complex immune-related toxicities. The investigators will perform a detailed study of cancer patients receiving checkpoint inhibitors. Saliva and a series of stool samples will be collected from each patient to analyse their microbiome and will be linked to treatment response, by examining blood samples and - if available - tumour and organ samples. The investigators hope this work will enable personalisation of patient immunotherapies based on microbiome biomarkers, as well as precisely manipulate a patient's microbiota to optimise their immunotherapy. In addition, participants who have consented to take part in an optional sub-study may be offered a single nasopharyngeal swab for COVID-19 antigen before study entry. The investigators hope that that this identify correlations between the microbiome and COVID-19. Comparison with a limited cohort of healthy household members (up to 360 volunteers) acting as controls will provide additional essential information about the role of the patient-specific microbiome.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Royal United Hospitals Bath NHS Foundation Trust, Bath, , United Kingdom

University Hospitals Dorest NHS Foundation Trust, Bournemouth, , United Kingdom

University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom

Velindre University NHS Trust, Cardiff, , United Kingdom

Western General Hospital, Edinburgh, , United Kingdom

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, King's Lynn, , United Kingdom

University Hospitals of Leicester NHS Foundation Trust, Leicester, , United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom

University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom

Somerset NHS Foundation Trust, Taunton, , United Kingdom

Royal Cornwall Hospitals NHS Trust, Truro, , United Kingdom

Contact Details

Name: Pippa Corrie

Affiliation: Cambridge University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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