EMBRACER study, version 1.1
Research type
Research Study
Full title
EMBRACER study: Evaluation of the microbiome in patients receiving systemic anti-cancer treatment for biliary tract cancer.
IRAS ID
298821
Contact name
Roseanna Wheatley
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 0 months, days
Research summary
The microbiome is the collective term for microorganisms (such as bacteria and fungi) that are found in certain areas of the body, including the digestive system. Studies have shown the role of the microbiome in cancer development, growth, and response to treatment, but further research is needed to understand the role of the microbiome in biliary tract cancer. Opportunities exist to change the microbiome through interventions such as antibiotics and diet.
Biliary tract cancer refers to cancer of the biliary system (consists of the liver, gallbladder and bile ducts), part of the digestive system. Patients with biliary tract cancer may have a poor prognosis and often present with disease that is not curable. Understanding the different types of bacteria and fungi in patients with biliary tract cancer may enable future studies exploring the potential to alter the microbiome and optimise benefit from treatment.
This study will assess the oral (mouth) and gut microbiome environment in patients with biliary tract cancer receiving chemotherapy in the adjuvant or first-line advanced setting, and explore whether there is an association between the microbiome and patient outcomes, including response to treatment and survival.
Participants will be recruited at The Christie NHS Foundation Trust and will be required to provide saliva and stool samples before starting chemotherapy. Repeat samples will be taken on treatment with chemotherapy, or at the end of treatment. Each participant will remain in the study for 12 months, and will be monitored on treatment as per standard of care. The results of the study will be presented, published, and made publicly available once completed.
Lay summary of study results: Biliary tract cancer refers to cancer of the biliary system which consists of the liver, gallbladder and bile ducts. Patients with biliary tract cancer have a poor prognosis and often present with advanced disease that is not amenable to surgery. The bacteria that normally live in the bowel (the gut microbiome) and the mouth (the oral microbiome) vary from person to person and current evidence shows that a loss of diversity (reduction in variety of types of bacteria) and an altered microbiome composition is involved in many diseases, including cancer.
EMBRACER study (Evaluation of the microbiome in patients receiving systemic anti-cancer treatment for biliary tract cancer) was a prospective observational study, which involved patients providing saliva and stool samples for microbiome analysis. The aim of the study was to evaluate the microbiome of patients with biliary tract cancer and explore its relationship with clinical information (including antibiotic use, presence of a biliary stent, and disease stage) and how effective treatment was.
Fifty patients were recruited to the study at The Christie NHS Foundation Trust between February and September 2022. Thirteen patients received chemotherapy in the adjuvant (after surgery) setting and 37 patients received chemotherapy for advanced disease. The study showed that specific types of oral and gut microbiota are associated with presence of a biliary stent and disease stage in patients receiving chemotherapy for biliary tract cancer. Treatment effectiveness was not impacted by the microbiome. We also observed an altered gut microbiome composition in patients who had received antibiotics within eight weeks before, and four weeks after, initiation of chemotherapy.
As the first-line standard of care treatment for advanced stage biliary tract cancer is now combined chemotherapy and immunotherapy, this study provides useful context for future studies which will include the addition of immunotherapy.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0222
Date of REC Opinion
31 Jan 2022
REC opinion
Further Information Favourable Opinion