RecruitingNCT04804956

Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer

Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment


Sponsor

University Hospital of Girona Dr. Josep Trueta

Enrollment

100 participants

Start Date

Apr 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether the types of bacteria living in and around rectal tumors (the microbiome) can predict how well a patient responds to treatment and their overall survival after surgery for rectal cancer. **You may be eligible if...** - You are 18 or older - You have rectal cancer confirmed by biopsy (adenocarcinoma or adenoma) - You are scheduled for surgical removal of the rectum - Your surgery aims to remove all cancer (R0 resection) - You may or may not have received radiation or chemotherapy before surgery **You may NOT be eligible if...** - You have a condition preventing safe surgery - You do not have confirmed rectal cancer - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREStool sample

One stool sample will be taken at baseline for microbiota characterization

PROCEDURERectal mucosa sample

Characterization of tissue microbiota before and after surgery.

PROCEDUREMesorectal adipose tissue sample

Characterization of tissue microbiota and dysfunction

PROCEDURESubcutaneous adipose tissue sample

Characterization of tissue microbiota and dysfunction

PROCEDUREVisceral adipose tissue sample

Characterization of tissue microbiota and dysfunction

BEHAVIORALDietary assessment

Dietary assessment will be taken at baseline


Locations(1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04804956


Related Trials