Mesorectal Microbiome as a Prognostic Factor in Patients With Rectal Cancer
NCT ID: NCT04804956
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-04-01
2026-04-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Stool sample
One stool sample will be taken at baseline for microbiota characterization
Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Dietary assessment
Dietary assessment will be taken at baseline
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.
Stool sample
One stool sample will be taken at baseline for microbiota characterization
Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Dietary assessment
Dietary assessment will be taken at baseline
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.
Stool sample
One stool sample will be taken at baseline for microbiota characterization
Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Dietary assessment
Dietary assessment will be taken at baseline
Interventions
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Stool sample
One stool sample will be taken at baseline for microbiota characterization
Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Dietary assessment
Dietary assessment will be taken at baseline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
18 Years
ALL
No
Sponsors
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Girona Biomedical Research Institute
UNKNOWN
University Hospital of Girona Dr. Josep Trueta
NETWORK
Responsible Party
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Antoni Codina Cazador, PhD, MD
Principal Investigator
Locations
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Hospital Universitari Dr. Josep Trueta de Girona
Girona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2012.028
Identifier Type: -
Identifier Source: org_study_id
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