NCT04804956Recruiting
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 Mar 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- University Hospital of Girona Dr. Josep Trueta
- Diseases
- Colorectal cancer
- NCT number
- NCT04804956
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Apr 2021 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency Surgery
- Clinical symptoms and sings of infection in the previous month
- Excessive alcohol intake or drug abuse
Other illness
- History of colorectal cancer surgery different to the local excision
- Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- Another synchronous malignancy
- Severe kidney or liver disease
- Systemic disease with inflammatory activity, such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (HIV,TBC).
- Severe disorder of eating behaviour
- Major psychiatric antecedents
Other
- Colorectal tumor with different histology to adenocarcinoma or adenoma
- Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- Any patient that medical characteristics present an individual risk raised to be included and complete the study
- Pregnancy and lactation
- Antibiotic, antifungal and antiviral treatment for the last 3 months
- Anti-inflammatory chronic treatment
Who the study is looking for
- 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
Age in the registry: 18 years to 18 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Dr. Josep Trueta de Girona Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.