Rectal Cancer
Conditions
Keywords
Rectal Neoplasms, Colorectal surgery, Gastrointestinal Microbiome, Metabolomics, Microbiome
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.
Detailed description
The 5-year survival rate for patients with rectal cancer is 64%. Despite the development of personalized cancer treatments, the implantation of surgical approaches with more precise fields of vision and the current prognostic factors based on the quality of resection of the surgical specimen (intact margins and complete resection of the mesorectum), the long-term results for patients with rectal cancer remain grim. Recently, it has been shown that dysfunctional fat tissue is characterized by tissue remodeling, grater lipids deposits and high adipokines secretion generates a pro inflammatory state, hypoxia and angiogenesis. These products generated by dysfunctional peritumoral adipose tissue create an ideal microenvironment for initiation and tumor progression. The presence of microbiome in the mesentery of patients with colitis has confirmed the translocation of microorganisms from the intestine to adjacent tissues, together with the differences found in the bacterial composition in colonic mucosa and fecal samples between patients with rectal cancer and healthy individuals, and the prognosis value of the quality of mesorectum resection suggests that the microbiome present in lymph-fatty tissue in patients with rectal cancer may be a key element in mesorectum dysfunction, progression and dissemination of oncological disease.
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
Sponsors
University Hospital of Girona Dr. Josep Trueta
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation | Up to 1 month after rectal cancer surgery | Qualitative and quantitative analysis of the microbiome and metabolome of adipose tissue, feces, and rectal mucosa in patients with rectal cancer |
| Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis | Up to 1 month after rectal cancer surgery | Analysis of adipose tissue, fecal and rectal mucosa dysfunctionality tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis |
| Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response | Up to 1 month after rectal cancer surgery | Correlation between adipose tissue, fecal and rectal mucosa dysfunction and response to neoadjuvant treatment |
Countries
Spain
Contacts
CONTACTAntoni Codina Cazador, MD, PhD
Outcome results
None listed