Gut Microbiota, Anastomotic Leak and Colorectal Cancer | NCT04071964

Studies
Gut Microbiota, Anastomotic Leak and Colorectal Cancer

NCT04071964

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Unknown status

Last Update Posted

May 16, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2019Actual

Primary Completion Date

Jul 9, 2025Estimated

Completion Date

Jul 9, 2025Estimated

First Submitted Date

Aug 26, 2019

First Submission Date that Met QC Criteria

Aug 26, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

Detailed Description

No more details required

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with an anastomotic leak	Clinical and/or radiological anastomotic leak	1 month

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with cancer reoccurence	Colorectal cancer local or distant reoccurence	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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")

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier de l'Université de Montréal		Montreal	Quebec	H2X 3E4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided