Status:
TERMINATED
Microbiome in Colorectal Cancer Onset and Progression
Lead Sponsor:
Viome
Conditions:
Colorectal Cancer
Tumor
Eligibility:
All Genders
50-80 years
Brief Summary
This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/...
Detailed Description
This is an exploratory, longitudinal study that will follow approximately 1,000 participants over 4-6 clinical sites nationwide over a period of 3-4 years and collect molecular and phenotype data to o...
Eligibility Criteria
Inclusion
- Age 50-80
- with a signed Informed Consent Form
- able to comply with the protocol requirements AND
- Confirmed primary diagnosis of colorectal cancer (stage I (1), II (2) and III (3)), or pre-- cancerous polyps, including tubulovillous or villous adenomas, with a biopsy available for study assays OR
- CRC-free and polyp-free colon using colonoscopy
Exclusion
- Diagnosis of CRC relapse at the time of enrollment
- Inflammatory bowel disease
- Irritable bowel syndrome (IBS), confirmed at enrollment
- Pregnant, planning to become pregnant during the study timeline or nursing
- Cholecystectomy (gallbladder removal)
- Bariatric/gastric surgery
- Partial colectomy (colon removal)
- Partial bowel resection
- Pancreatic surgery
- Lynch syndrome
- Familial polyposis
- Patients from which the healthcare providers do not collect biopsy at colonoscopy AND undergo neoadjuvant therapy prior to surgery (the microbial composition of the biopsy at the time of surgery may be significantly affected by neoadjuvant therapy).
- Known autoimmune condition or impairment of immunological functions (e.g. HIV infection)
- Medications: Receipt of biologics, systemic immunosuppressive therapy, incl. cancer therapy, or antibiotics in the last 3 months before initial diagnosis
- Any vaccine taken within the last 30 days
- Current receipt of investigational agent
Key Trial Info
Start Date :
June 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05368688
Start Date
June 30 2022
End Date
December 22 2022
Last Update
December 27 2022
Active Locations (1)
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1
Washington Gastroenterology
Bellevue, Washington, United States, 98004