Microbiome in Colorectal Cancer Onset and Progression

NCT05368688 | Terminated

• 1 other identifier: V242
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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/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.

Conditions

Colorectal Cancer; Tumor; CRC; GI Cancer; Gastrointestinal Cancer

Keywords

Fusobacterium nucleatum; Microbiome; Viome; Biopsy; Intestinal Permeability; Colonoscopy; Surgical resection; stool; urine; saliva; blood

Outcome Measures

Primary Outcomes (1)

• The molecular features of Fusobacterium (Fn) correlated with colorectal cancer (onset, recurrence, metastasis and survival)

  Determine Fn species and strains, more specifically the prevalence and relative activity, and the differential gene expression and key pathways. The Investigators will also look at Microbial co-occurrence/abundance with Fn and local tumor microenvironment and tumor marker/mutations and their association with microbiome.

  6 years

Study Arms (5)

Cancer-free

Have confirmed colorectal cancer-free and Polyp-free colon using colonoscopy

Pre-cancerous

Have benign or precancerous polyps, including tubulovillous or villous adenomas, using colonoscopy

Colorectal cancer stage I

Have confirmed TNM staging of colorectal cancer The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor. The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.

Colorectal cancer stage II

Have confirmed TNM staging of colorectal cancer The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor. The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.

Colorectal cancer stage III

Have confirmed TNM staging of colorectal cancer

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited into the following study groups: Cancer-free subjects (confirmed CRC-free via colonoscopy) Precancerous stage participants Stage I (1) colorectal cancer participants Stage II (2) colorectal cancer participants Stage III (3) colorectal cancer participants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Momchilo Vuyisich, PhD

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 10, 2022
• Study Start: June 30, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

US (1)