Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer
BIORECTUM
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
June 10, 2026
June 1, 2026
6 years
March 15, 2021
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Correlation between mesorectal microbial and metabolomic signatures and survival
Up to 5 years after rectal cancer surgery
Secondary Outcomes (3)
Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation
Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis
Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response
Up to 1 month after rectal cancer surgery
Study Arms (5)
Early-rectal cancer
The patients to be included in this group will be those with Stage I (initial tumor stage). The tumors classified in stage I will be tumors in which the invasion of the submucosa and / or the invasion of the muscularis propria occur. This group will include patients diagnosed preoperatively with tumor stage T1-T2 N0.
Advanced-rectal cancer
The patients to be included in this group will be those with Stages II and III, that is, advanced tumors at the time of preoperative diagnosis. Tumors included in this group invade the perirectal fat and / or the surface of the visceral peritoneum and / or invade or adhere to adjacent organs or structures. In addition, any tumor stage with lymph nodes without distant metastases will be included in this group.
Synchronous metastasis -rectal cancer
The patients to be included in this group will be those with Stage IV (disseminated tumor stage) in the initial study of the disease. Patients with distant metastases in one organ or more than one organ will be included.
Control group
Patients diagnosed with non-oncological disease
Patients diagnosed with colon cancer
Patients diagnosed with colon cancer who require elective surgery.
Interventions
Dietary assessment will be taken at baseline
Characterization of tissue microbiota and dysfunction
Characterization of tissue microbiota and dysfunction
One stool sample will be taken at baseline for microbiota characterization
Characterization of tissue microbiota before and after surgery.
Characterization of tissue microbiota and dysfunction
Eligibility Criteria
Patients diagnosed with rectal cancer
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, 17007, Spain
Biospecimen
Whole blood, faeces, rectal mucosa, mesorectal, subcutaneous and visceral adipose tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 18, 2021
Study Start
April 1, 2021
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
June 10, 2026
Record last verified: 2026-06