Status:
RECRUITING
Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer
Lead Sponsor:
University Hospital of Girona Dr. Josep Trueta
Collaborating Sponsors:
Girona Biomedical Research Institute
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-18 years
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. ...
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 a...
Eligibility Criteria
Inclusion
- Patients with rectal cancer that will undergo anterior resection for rectal cancer.
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04804956
Start Date
April 1 2021
End Date
April 1 2026
Last Update
October 6 2021
Active Locations (1)
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1
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain, 17007