Exploring the role of the mesorectal microbiome in rectal cancer prognosis
Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment
This study is trying to see if the bacteria in the gut of people with rectal cancer can help predict how well they will do after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital of Girona Dr.Josep Trueta Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Girona) |
| Trial ID | NCT04804956 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mesorectal microbiome in patients with rectal cancer to identify microbial profiles that may predict poor prognosis. By analyzing stool samples, rectal mucosa, and various adipose tissue samples, researchers will explore the relationship between microbiome alterations and cancer progression. The study focuses on patients undergoing anterior resection for rectal cancer, with the goal of enhancing prognostic factors beyond traditional surgical outcomes. The findings could provide insights into the role of gut microorganisms in cancer pathogenesis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed rectal adenocarcinoma who are scheduled for anterior resection.
Not a fit: Patients with colorectal tumors of histology other than adenocarcinoma or those with severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for rectal cancer patients, potentially guiding more personalized treatment approaches.
How similar studies have performed: While the role of the microbiome in various cancers has been explored, this specific focus on the mesorectal microbiome in rectal cancer is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Girona
- Hospital Universitari Dr. Josep Trueta de Girona — Girona, Spain (Recruiting)
Study contacts
- Study coordinator: Antoni Codina Cazador, MD, PhD
- Email: acodinac.girona.ics@gencat.cat
- Phone: +34972940256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.