Hospital Universitari Dr. Josep Trueta de Girona
Girona, 17007, Spain
Location status: Recruiting
NCT Number: NCT04804956
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.
Interested in participating?
Request Info18 year–18 year
All sexes
Observational
Girona, 17007, Spain
Location status: Recruiting
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 and the current prognostic factors based on the quality of resection of the surgical specimen (intact margins and complete resection of the mesorectum), the long-term results for patients with rectal cancer remain grim.
Recently, it has been shown that dysfunctional fat tissue is characterized by tissue remodeling, grater lipids deposits and high adipokines secretion generates a pro inflammatory state, hypoxia and angiogenesis. These products generated by dysfunctional peritumoral adipose tissue create an ideal microenvironment for initiation and tumor progression.
The presence of microbiome in the mesentery of patients with colitis has confirmed the translocation of microorganisms from the intestine to adjacent tissues, together with the differences found in the bacterial composition in colonic mucosa and fecal samples between patients with rectal cancer and healthy individuals, and the prognosis value of the quality of mesorectum resection suggests that the microbiome present in lymph-fatty tissue in patients with rectal cancer may be a key element in mesorectum dysfunction, progression and dissemination of oncological disease.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Characterization of tissue microbiota and dysfunction
Characterization of tissue microbiota and dysfunction
Dietary assessment will be taken at baseline
Time frame: Up to 5 years after rectal cancer surgery
Correlation between mesorectal microbial and metabolomic signatures and survival
Time frame: Up to 1 month after rectal cancer surgery
Qualitative and quantitative analysis of the microbiome and metabolome of adipose tissue, feces, and rectal mucosa in patients with rectal cancer
Time frame: Up to 1 month after rectal cancer surgery
Analysis of adipose tissue, fecal and rectal mucosa dysfunctionality tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis
Time frame: Up to 1 month after rectal cancer surgery
Correlation between adipose tissue, fecal and rectal mucosa dysfunction and response to neoadjuvant treatment
Contact information is provided by the study sponsor or research team.
University Hospital of Girona Dr. Josep Trueta
Network
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment
Acronym: BIORECTUM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04098471
Colorectal Neoplasms, Digestive System Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT07104604
Colorectal Neoplasms, Digestive System Diseases
Shantou, Guangdong, China
View Trial DetailsNCT06340646
Adenocarcinoma, Blood Protein Disorders
St Louis, Missouri, United States
View Trial DetailsNCT06205485
Colorectal Neoplasms, Digestive System Diseases
Phoenix, Arizona, United States
View Trial Details