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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorUniversity Hospital of Girona Dr. Josep Trueta

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Stool sample
  • Rectal mucosa sample
  • Mesorectal adipose tissue sample
  • Subcutaneous adipose tissue sample
  • Visceral adipose tissue sample
  • Dietary assessment

Treatment groups

100 Participants
are divided into 5 treatment groups

Sponsors and collaborators

University Hospital of Girona Dr. Josep Trueta

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Sponsor institution

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Collaborator