Microbiome in Colorectal Cancer Onset and Progression

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/or progression. This is an approximately three-year study. There are two phases to this study, including: 1) pilot phase, 2) full study. There are also five arms in this study including cancer-free, pre-cancerous, and Colorectal cancer stages (I-III). The pilot study will include the recruitment of 50 participants per group (i.e., total of 250 participants). The full study will have an additional 150 participants per group (total of 1,000 participants). This study will recruit using clinical sites in the United States. There are 5 timepoints in this study. If the participants are found to be medically eligible through diagnosis and medical information, they will provide samples (including: saliva, blood, urine, stool and tumor biopsy) at each timepoint and during the study. They will also answer health and wellness questions during this study. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). The participant's healthcare provider will determine if additional biopsies are required as a part of the standard of care. If collected, additional samples will be sent for research purposes.

Sex

All

Minimum age

50 Years

Maximum age

80 Years

Inclusion Criteria:

* 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 Criteria:

* 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