Colorectal CancerNCT04071964
Gut Microbiota, Anastomotic Leak and Colorectal Cancer
An observational study of Colorectal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior. Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2019to 9 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)
Who may be able to join
- Age 18 years and older
- CRC diagnosis
- Upcoming colonic and/or rectal resection with/without anastomosis
- Individuals without diseases of the colon and rectum (healthy controls)
Who cannot join
- Pregnancy
- Previous stoma
- Bowel surgery in the last 4 weeks prior to the surgery
- Secondary objectives, inclusion criteria are as follows:
- Age 18 years and older
- Rectal cancer diagnosis with histopathological confirmation
- Abdominoperineal resection with terminal colostomy
- Expectative non-surgical management ("Watch and wait approach")
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior.
Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.
Read the detailed description
No more details required
- Conditions
- Colorectal Cancer
- Keywords
- Microbiota
- Medical subject headings
- Colorectal 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 |
|---|---|---|
| Groupe 1 | Patients with colorectal cancer undergoing resection with anastomosis | |
| Groupe 2 | Patients with colorectal cancer undergoing resection without anastomosis (Abdominoperineal resection) | |
| Groupe 3 | Patients with rectal cancer without surgery ("Watch and wait") | |
| Groupe 4 | Control group consisting of patients who do not have surgical pathologies of the colon and rectum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an anastomotic leak
Clinical and/or radiological anastomotic leak
Measured: 1 month
Secondary outcomes (1)
Number of participants with cancer reoccurence
Colorectal cancer local or distant reoccurence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Jul 2019
- Primary completion9 Jul 2025 (estimated)
- Study completion9 Jul 2025 (estimated)
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 Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071964
- Sponsor's protocol ID
- 19.021-YP,2020-8305
- Status last verified
- May 2024
- First submitted
- 26 Aug 2019
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota, Anastomotic Leak and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04071964
- Acronym / sponsor ID
- 19.021-YP,2020-8305
- Conditions
- Colorectal Cancer
- Keywords
- Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 9 Jul 2025 (estimated)
- Study completion
- 9 Jul 2025 (estimated)
- First posted
- 28 Aug 2019 (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 a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior.
Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.
Detailed description
No more details required
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Groupe 1 | – | –Patients with colorectal cancer undergoing resection with anastomosis |
| Groupe 2 | – | –Patients with colorectal cancer undergoing resection without anastomosis (Abdominoperineal resection) |
| Groupe 3 | – | –Patients with rectal cancer without surgery ("Watch and wait") |
| Groupe 4 | – | –Control group consisting of patients who do not have surgical pathologies of the colon and rectum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)
Key inclusion criteria (4 listed)
- Age 18 years and older
- CRC diagnosis
- Upcoming colonic and/or rectal resection with/without anastomosis
- Individuals without diseases of the colon and rectum (healthy controls)
Key exclusion criteria (8 listed)
- Pregnancy
- Previous stoma
- Bowel surgery in the last 4 weeks prior to the surgery
- Age 18 years and older
- Rectal cancer diagnosis with histopathological confirmation
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
Number of participants with an anastomotic leak
Time frame: 1 month
Clinical and/or radiological anastomotic leak
1 secondary outcome
Number of participants with cancer reoccurence
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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 Canada. 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?
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?
Number of participants with an anastomotic leak (time frame: 1 month). 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 16 May 2024.