Colorectal CancerNCT05368688
Microbiome in Colorectal Cancer Onset and Progression
An observational study of Colorectal Cancer and Tumor, run by Viome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Tumor, CRC
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 22 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Gastroenterology
Bellevue, Washington, 98004
About this study
Official title: The Role of the 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.
Read the 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 obtain insights into the microbiome and colorectal cancer. Each site will enroll approximately 166-250 participants in total. Those that are polyp/cancer free, pre-cancerous and confirmed primary diagnosis of colorectal cancer (stage I, II and III) will be recruited. Participants will be recruited in primary, secondary, and tertiary care centers, depending on the study inclusion/exclusion criteria.
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
- Colorectal Cancer, Tumor, CRC, GI Cancer, Gastrointestinal Cancer
- Keywords
- Fusobacterium nucleatum, Microbiome, Viome, Biopsy, Intestinal Permeability, Colonoscopy, Surgical resection, stool, urine, saliva, blood
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start30 Jun 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Why it stopped: Recruitment rate was too low to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, PhD, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368688
- Sponsor's protocol ID
- V242
- Status last verified
- Dec 2022
- First submitted
- 26 Apr 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiome in Colorectal Cancer Onset and Progression
- ClinicalTrials.gov ID
- NCT05368688
- Acronym / sponsor ID
- V242
- Conditions
- Colorectal Cancer, Tumor, CRC, GI Cancer, Gastrointestinal Cancer
- Keywords
- Fusobacterium nucleatum, Microbiome, Viome, Biopsy, Intestinal Permeability, Colonoscopy, Surgical resection, stool
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment rate was too low to continue the study.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 obtain insights into the microbiome and colorectal cancer. Each site will enroll approximately 166-250 participants in total. Those that are polyp/cancer free, pre-cancerous and confirmed primary diagnosis of colorectal cancer (stage I, II and III) will be recruited. Participants will be recruited in primary, secondary, and tertiary care centers, depending on the study inclusion/exclusion criteria.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The molecular features of Fusobacterium (Fn) correlated with colorectal cancer (onset, recurrence, metastasis and survival)
Time frame: 6 years
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.
Results and safety
The study was stopped early (reason given: Recruitment rate was too low to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momchilo Vuyisich, PhD principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Tumor, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment rate was too low to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The molecular features of Fusobacterium (Fn) correlated with colorectal cancer (onset, recurrence, metastasis and survival) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.