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Clinical Trials in Spain / NCT04804956
Recruiting Observational

Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer

NCT04804956 · tracked via the Priya Life Science Spain tracker
Sponsor
University Hospital of Girona Dr. Josep Trueta
Phase
Observational
Started
2021-04-01
Last updated
2026-06-10

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Stool sampleRectal mucosa sampleMesorectal adipose tissue sampleSubcutaneous adipose tissue sampleVisceral adipose tissue sampleDietary assessment

Stool sample: One stool sample will be taken at baseline for microbiota characterization

Rectal mucosa sample: Characterization of tissue microbiota before and after surgery.

Mesorectal adipose tissue sample: Characterization of tissue microbiota and dysfunction

Subcutaneous adipose tissue sample: Characterization of tissue microbiota and dysfunction

Visceral adipose tissue sample: Characterization of tissue microbiota and dysfunction

Dietary assessment: Dietary assessment will be taken at baseline

Study 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

Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with colorectal cancer that will undergo elective surgery * Patients diagnosed with non-oncological disease with an indication for elective surgery. * Age ≥ 18 years * Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy * Tumoral stage equal or grater than T1 * Attempt to R0 resection * Signed informed consent by the patient and by the researcher * Dietary Questionnaire completed Exclusion Criteria: * Colorectal tumor with different histology to adenocarcinoma or adenoma * History of colorectal cancer surgery different to the local excision * Patients with psychiatric illness, addiction or disorder with inability to understand informed consent * Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish) * Another synchronous malignancy * Emergency Surgery * Any patient that medical characteristics present an individual risk raised to be included and complete the study * Severe kidney or liver disease * Systemic disease with inflammatory activity, such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (HIV,TBC). * Pregnancy and lactation * Severe disorder of eating behaviour * Clinical symptoms and sings of infection in the previous month * Antibiotic, antifungal and antiviral treatment for the last 3 months * Anti-inflammatory chronic treatment * Major psychiatric antecedents * Excessive alcohol intake or drug abuse

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari Dr. Josep Trueta de Girona Girona Girona Recruiting

Other trials for the same condition

Patient Reported Outcomes Following Cancer of the Rectum Recruiting
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors Active, not recruiting
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS) Starting soon
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment Recruiting
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04804956 on ClinicalTrials.gov ↗ ← All trials in Spain