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

Recruitingn/aAges 18 Years - 18 YearsAllUniversity Hospital of Girona Dr. Josep Trueta
NCT04804956 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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
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What it tests

  • Stool sample
  • Rectal mucosa sample
  • Mesorectal adipose tissue sample
  • Subcutaneous adipose tissue sample
  • Visceral adipose tissue sample
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Where

1 site
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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