Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary assessment | Behavioral | — | UNRESOLVED |
| Mesorectal adipose tissue sample | Procedure | — | UNRESOLVED |
| Rectal mucosa sample | Procedure | — | UNRESOLVED |
| Stool sample | Procedure | — | UNRESOLVED |
| Subcutaneous adipose tissue sample | Procedure | — | UNRESOLVED |
| Visceral adipose tissue sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Early-rectal cancer
- description
- 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.
- interventionNames
- Procedure: Stool sample
- Procedure: Rectal mucosa sample
- Procedure: Mesorectal adipose tissue sample
- Procedure: Subcutaneous adipose tissue sample
- Procedure: Visceral adipose tissue sample
- Behavioral: Dietary assessment
- label
- Advanced-rectal cancer
- description
- 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.
- interventionNames
- Procedure: Stool sample
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available