Microbiome and Colorectal Cancer Recurrence | NCT07057076

Studies
Microbiome and Colorectal Cancer Recurrence

NCT07057076

Sponsor

Hospital del Mar

Status

Completed

Last Update Posted

Jul 9, 2025Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Colorectal Cancer Recurrent

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
PI19/00643	Other Grant/Funding Number	Institute of Health Carlos III
SGR 00024	Other Grant/Funding Number	Agency for Management of University and Research Grants (AGAUR)

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2004Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Jun 29, 2025

First Submission Date that Met QC Criteria

Jun 29, 2025

First Posted Date

Jul 9, 2025Actual

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

Jun 29, 2025

Last Update Posted Date

Jul 9, 2025Actual

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

Anastomotic leak is associated with higher rates of tumor recurrence after colorectal cancer surgery. However, the mechanisms responsible remain unknown. The aim of this study is to identify associations between the peritoneal microbiome and recurrence in colorectal cancer patients with postoperative anastomotic leak. This is a single-center retrospective study of patients undergoing colorectal cancer surgery complicated with anastomotic leak between 2004 and 2012. Samples of peritoneal fluid were collected either through percutaneous drainage or reoperation, and microbiome was analyzed using whole genome shotgun. Oncological outcomes are registered. Associations between peritoneal microbiome and tumor recurrence are investigated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colorectal cancer patients		Colorectal cancer patients operated on for cure and complicated by anastomotic leak

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence	Colorectal cancer recurrence after surgery	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal cancer patients operated on for cure and complicated with anastomotic leak.

Exclusion Criteria:

Non-curative resection.
Urgent surgery.

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

Colorectal cancer patients operated on for cure and complicated with anastomotic leak.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D057868	Anastomotic Leak
D012008	Recurrence

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