Brief Summary

The equilibrium of intestinal microorganisms is essential for health an imbalance has been associated with an increased risk in the development of different pathologies; including colorectal cancer. Rectal cancer is the third most common neoplasm worldwide and the complete excision of the mesorectum is a major prognostic factor. The identification of microorganisms in the adipose tissue that surrounds the small intestine in inflammatory diseases, together with bacterial alterations found in colonic mucosa and feces in patients with rectal cancer in comparison with healthy individuals indicates that microbiome alteration plays an essential role in pathogenesis. The mesorectal microbiome in rectal cancer patients stills unknown and given its importance in the prognostic of the disease the goal of this study is to identify microbial profiles that allow predicting rectal cancer patients with a poor prognosis.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

March 15, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed

14 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

March 15, 2021

Last Update Submit

September 28, 2021

Conditions

Rectal Cancer

Keywords

Rectal NeoplasmsColorectal surgeryGastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

Identification of mesorectal microbial biomarkers as prognostic factor for rectal cancer
Correlation between mesorectal microbial signatures and survival
Up to 5 years after rectal cancer surgery

Secondary Outcomes (3)

Mesorectal microbiome evaluation
Up to 1 month after rectal cancer surgery
Evaluation of mesorectal dysfunctionality and its correlation with microbial dysbiosis
Up to 1 month after rectal cancer surgery
Evaluation of mesorectal dysfunctionality and dysbiosis on tumor progression
Up to 1 month after rectal cancer surgery

Study Arms (3)

Early-rectal cancer

The patients to be included in this group will be those with Stage I (initial tumor stage). The tumors classified in stage I will be tumors in which the invasion of the submucosa and / or the invasion of the muscularis propria occur. This group will include patients diagnosed preoperatively with tumor stage T1-T2 N0.

Procedure: Stool sampleProcedure: Rectal mucosa sampleProcedure: Mesorectal adipose tissue sampleProcedure: Subcutaneous adipose tissue sampleProcedure: Visceral adipose tissue sampleBehavioral: Dietary assessment

Advanced-rectal cancer

The patients to be included in this group will be those with Stages II and III, that is, advanced tumors at the time of preoperative diagnosis. Tumors included in this group invade the perirectal fat and / or the surface of the visceral peritoneum and / or invade or adhere to adjacent organs or structures. In addition, any tumor stage with lymph nodes without distant metastases will be included in this group.

Synchronous metastasis -rectal cancer

The patients to be included in this group will be those with Stage IV (disseminated tumor stage) in the initial study of the disease. Patients with distant metastases in one organ or more than one organ will be included.