Colonic NeoplasmsNCT02151123
Metabiomics Colon Cancer Clinical Research Study
An observational study of Colonic Neoplasms, run by Metabiomics Corp at 1 site in United States.
Trial summary
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colonic Neoplasms
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to Sep 2020
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado
Who may be able to join
- Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
- Male or female,
- Age: 18-95 years,
- Able to comprehend, sign, and date the written informed consent form (ICF),
- Able to give informed consent in English
- Women and minorities will be included.
Who cannot join
- History of Inflammatory Bowel Disease
- Antibiotics within 2 weeks of sample collection.
- Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
- Any radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.
Read the detailed description
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, Colon Cancer, Microbiome
- Medical subject headings
- Colonic 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 |
|---|---|---|
| Diagnosed colon cancer patients | Patients undergoing colectomy for colonic adenocarcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate of test for colon cancer
The False Negative Rate is calculated as (100*False Negative) /(True Positive + False Negative).
Measured: immediately post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: funding not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabiomics Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Vogel, MD, Principal investigator, University of Colorado School of Medicine Anschutz Medical CampusChristopher Lieu, MD, Principal investigator, University of Colorado School of Medicine Anschutz Medical CampusPatrick Gillevet, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151123
- Sponsor's protocol ID
- MB-02_CU
- Status last verified
- Aug 2018
- First submitted
- 27 May 2014
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabiomics Colon Cancer Clinical Research Study
- ClinicalTrials.gov ID
- NCT02151123
- Acronym / sponsor ID
- MB-02_CU
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, Colon Cancer, Microbiome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Metabiomics CorpIndustry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 30 May 2014 (estimated)
- 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.
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.
Detailed description
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed colon cancer patients | – | –Patients undergoing colectomy for colonic adenocarcinoma. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado
Key inclusion criteria (6 listed)
- Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
- Male or female,
- Age: 18-95 years,
- Able to comprehend, sign, and date the written informed consent form (ICF),
- Able to give informed consent in English
Key exclusion criteria (4 listed)
- History of Inflammatory Bowel Disease
- Antibiotics within 2 weeks of sample collection.
- Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
- Any radiation therapy
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
False negative rate of test for colon cancer
Time frame: immediately post surgery
The False Negative Rate is calculated as (100*False Negative) /(True Positive + False Negative).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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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.
Jon Vogel, MD principal investigator
University of Colorado School of Medicine Anschutz Medical Campus
Christopher Lieu, MD principal investigator
University of Colorado School of Medicine Anschutz Medical Campus
Patrick Gillevet, PhD principal investigator
George Mason University
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 Colonic Neoplasms, run by Metabiomics Corp 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Sep 2025. 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 withdrawn before enrolling participants, so there are no results.
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?
False negative rate of test for colon cancer (time frame: immediately post surgery). 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 26 Sep 2025.