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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample | Procedure | One stool sample will be taken at baseline for microbiota characterization |
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer | Correlation between mesorectal microbial and metabolomic signatures and survival | Up to 5 years after rectal cancer surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation | Qualitative and quantitative analysis of the microbiome and metabolome of adipose tissue, feces, and rectal mucosa in patients with rectal cancer | Up to 1 month after rectal cancer surgery |
| Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with rectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoni Codina Cazador, MD, PhD | Contact | +34972940256 | acodinac.girona.ics@gencat.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Dr. Josep Trueta de Girona | Recruiting | Girona | Girona | 17007 | Spain |
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Whole blood, faeces, rectal mucosa, mesorectal, subcutaneous and visceral adipose tissue
| Control group | Patients diagnosed with non-oncological disease |
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| Patients diagnosed with colon cancer | Patients diagnosed with colon cancer who require elective surgery. |
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| Rectal mucosa sample | Procedure | Characterization of tissue microbiota before and after surgery. |
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| Mesorectal adipose tissue sample | Procedure | Characterization of tissue microbiota and dysfunction |
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| Subcutaneous adipose tissue sample | Procedure | Characterization of tissue microbiota and dysfunction |
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| Visceral adipose tissue sample | Procedure | Characterization of tissue microbiota and dysfunction |
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| Dietary assessment | Behavioral | Dietary assessment will be taken at baseline |
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Analysis of adipose tissue, fecal and rectal mucosa dysfunctionality tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis |
| Up to 1 month after rectal cancer surgery |
| Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response | Correlation between adipose tissue, fecal and rectal mucosa dysfunction and response to neoadjuvant treatment | Up to 1 month after rectal cancer surgery |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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