A Prospective Cohort Multi-Institutional Observational Study of the Gut Microbiota in Gastroenterological Cancer

JRCT ID: jRCT1030220239

Registered date:02/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastrointestinal cancer
• Date of first enrollment: 17/10/2019
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: To evaluate 5-year survival rate by distribution of gut microbiota by each primary tissue (esophageal cancer, stomach cancer, liver cancer, pancreatic cancer, biliary tract cancer, and colorectal cancer)

Secondary Outcome

/Relationship between treatment outcome of gastrointestinal cancer and intestinal microbiota (resectable, borderline resectable, unresectable)
/Relationship between the usefulness of preoperative and postoperative treatment and gut microbiota (significance of preoperative radiochemotherapy and preoperative pharmacotherapy, adjuvant pharmacotherapy, determination of treatment efficacy, adverse events, treatment completion rate, response rate, recurrence-free survival, cancer-specific survival, overall survival)
/Outcomes by surgical technique (surgical technique, extent of dissection and its method, reconstruction method, presence of vascular complications, presence of complications of resection of other organs)
/Perioperative complications and intestinal microbiota
/Evaluation of tumor infiltrating lymphocytes (in relation to intestinal microbiota)
/Evaluation of the content of postoperative complications (risk assessment of postoperative complications and gut microbiota)
/Pathophysiology and risk factors for complications during preoperative treatment (association between pathophysiology of complications such as diarrhea and cholangitis and intestinal microbiota)
/Treatment outcome by stage of progression (association between patients with invasion of other organs and distant metastasis (cStage IV) and intestinal microbiota)
/Treatment outcome by patient background (association between gut microbiota and obese patients (BMI, VFA, SFA), elderly patients, and patients with comorbidities (cardiac disease, lung disease, antiplatelet medication, etc.))
/Identification of gut microbiota (culture and genomics)
/Comparison of gut microbiota in cancerous, oral, and blood
/Comparison of intestinal microbiota in cancerous and non-cancerous areas
/Visualization of intestinal microbiota by fluorescent staining
/Relationship between the presence or absence of polypectomy and intestinal microbiota in postoperative follow-up of gastrointestinal cancer patients
/Association of gut microbiota with recurrence format and treatment outcome in postoperative recurrent cases of gastrointestinal cancer

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

/Be at least 18 years of age at the time of enrollment in this study
/Histologically confirmed to have gastrointestinal cancer.
/Gastrointestinal cancer is defined as esophageal cancer, stomach cancer, liver cancer, pancreatic cancer, biliary tract cancer, and colorectal cancer as defined in the Japanese Cancer Code.
/Surgical indications are not required.
/The participant has received a full explanation of the study and has given written consent.
/Blood test negative for infection (HCV antibody, HBs antigen, TPHA antibody, and HIV antibody)
/Participation in other observational studies is acceptable

• Exclude criteria: Patients deemed unsuitable for enrollment in this study by the physician

Related Information

• Primary Sponsor: Endo Itaru
• Secondary Sponsor: Japan Agency for Medical Research and Development