Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
63 participants
OBSERVATIONAL
2022-06-30
2022-12-22
Brief Summary
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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.
Detailed Description
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Participants complete surveys and collect samples including (blood, urine, stool, and saliva) using at-home/in-clinic kits provided by Viome. Participants are also asked to provide tissue or tumor samples if collected by their healthcare provider during a standard of care biopsy procedure. Biopsy samples for this test will be collected by the clinical staff at each study site. 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). Additionally, participants complete a survey sent on a quarterly basis.
There are 5 timepoints (TP) in this study including: Timepoint 1, Timepoint 2, Timepoint 3, Timepoint 4, and Timepoint 5.
TP1 includes the initial diagnosis where the stage of cancer is determined by imaging (colorectal cancer stages I, II, or III) or colonoscopy results (healthy and pre-cancerous). All participants provide urine, blood, saliva, stool and complete survey.
TP2 includes Post Standard of Care (SOC). For cancer participants, samples will be collected 45 +/- 15 days after all treatments have been completed (this includes chemotherapy, radiation therapy, immunotherapy, and/or surgery). Those that are healthy and pre-cancerous will provide their samples, 90 +/- 15 days after the colonoscopy. All participants provide urine, blood, saliva, stool and complete survey.
TP3, 4, and 5 occur 1, 2 and 3 years respectively after diagnosis (TP1) for cancer-free and precancerous groups and 1, 2 and 3 years respectively after standard of care therapy (TP2) for the cancer groups. All participants provide urine, blood, saliva, stool and complete survey.
Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Cancer-free
Have confirmed colorectal cancer-free and Polyp-free colon using colonoscopy
No interventions assigned to this group
Pre-cancerous
Have benign or precancerous polyps, including tubulovillous or villous adenomas, using colonoscopy
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Colorectal cancer stage III
Have confirmed TNM staging of colorectal cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
Yes
Sponsors
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Viome
INDUSTRY
Responsible Party
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Principal Investigators
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Momchilo Vuyisich, PhD
Role: PRINCIPAL_INVESTIGATOR
Viome
Locations
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Washington Gastroenterology
Bellevue, Washington, United States
Countries
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Other Identifiers
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V242
Identifier Type: -
Identifier Source: org_study_id