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Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 18
View:

• 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

Locations
Other Locations
Spain
Hospital Universitari Dr. Josep Trueta de Girona
RECRUITING
Girona
Contact Information
Primary
Antoni Codina Cazador, MD, PhD
acodinac.girona.ics@gencat.cat
+34972940256
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital of Girona Dr. Josep Trueta
Collaborators: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

This content was sourced from clinicaltrials.gov