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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.
Malignant neoplasms of digestive organs
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There is growing evidence that the microbiome (community of microorganisms that live in or on the human body) plays a role in the development of pancreatic cancer (PC) and its response to treatment. The relationship of tumour microbiome to gut microbiome is unknown and it is also unknown whether individuals at high risk of pancreatic cancer (HRI) have a unique predisposing gut microbiome.
Patients with PC often undergo Endoscopic ultrasound (EUS) guided biopsy to obtain small tissue samples for diagnosis, EUS is also used for annual surveillance of HRI.
We want to use the EUS procedure to enable the simultaneous study of the gut and tumour microbiome in patients with PC and the gut microbiome in HRI. Developing such a platform will lead to larger scale studies that could pave the way to new methods of screening, early diagnosis, and therapy.
We aim to recruit 40 PC patients, 10 HRI and 10 patients without pancreatic disease (as controls) undergoing routine EUS procedures. Saliva and stool samples will be obtained from all participants. PC patients will have EUS guided biopsy as routinely planned, and a small portion of the tumour biopsy will be retained for the study. All participants will additionally have small biopsies taken from the lining of the stomach and duodenum. Further tumour samples will be taken for the study from the removed tumour of participants who go on to have surgery. HRI who undergo annual EUS will have saliva and stool samples as well as stomach and duodenal biopsy samples taken at their routine EUS examination a year later. All samples will undergo analyses to determine what bacteria and fungi are present and in what proportions. The study is funded by Pancreatic cancer UK, participants will be recruited at the Freeman Hospital and samples analysed at Newcastle university.
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: Cohort study;
You can take part if:
You may not be able to take part if:
•Immunotherapy/chemotherapy within the past 6 months. •Immunosuppressive therapy. •Additional major diagnosis known to affect the gut microbiota (eg, liver cirrhosis, systemic sclerosis, inflammatory bowel disease). •Contraindication to pancreatic biopsy in the suspected cancer patients and contraindication to mucosal biopsy in all patients.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Newcastle Upon Tyne and funded by PANCREATIC CANCER UK .
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Read full details
for Trial ID: CPMS 64280
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