Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer (BIORECTUM)
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Antoni Codina Cazador, MD, PhD
- Telefonnummer: +34972940256
- E-Mail: acodinac.girona.ics@gencat.cat
Studienorte
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Girona
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Girona, Girona, Spanien, 17007
- Rekrutierung
- Hospital Universitari Dr. Josep Trueta de Girona
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Kontakt:
- Antoni Codina, MD, PhD
- Telefonnummer: 972940256
- E-Mail: acodinac.girona.ics@gencat.cat
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- 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
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
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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
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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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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
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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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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
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Control group
Patients diagnosed with non-oncological disease
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One stool sample will be taken at baseline for microbiota characterization
Characterization of tissue microbiota and dysfunction
Characterization of tissue microbiota and dysfunction
Dietary assessment will be taken at baseline
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Patients diagnosed with colon cancer
Patients diagnosed with colon cancer who require elective surgery.
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One stool sample will be taken at baseline for microbiota characterization
Characterization of tissue microbiota and dysfunction
Characterization of tissue microbiota and dysfunction
Dietary assessment will be taken at baseline
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Zeitfenster: Up to 5 years after rectal cancer surgery
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Correlation between mesorectal microbial and metabolomic signatures and survival
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Up to 5 years after rectal cancer surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation
Zeitfenster: Up to 1 month after rectal cancer surgery
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Qualitative and quantitative analysis of the microbiome and metabolome of adipose tissue, feces, and rectal mucosa in patients with rectal cancer
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Up to 1 month after rectal cancer surgery
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Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis
Zeitfenster: Up to 1 month after rectal cancer surgery
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Analysis of adipose tissue, fecal and rectal mucosa dysfunctionality tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis
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Up to 1 month after rectal cancer surgery
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Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response
Zeitfenster: Up to 1 month after rectal cancer surgery
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Correlation between adipose tissue, fecal and rectal mucosa dysfunction and response to neoadjuvant treatment
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Up to 1 month after rectal cancer surgery
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Darmerkrankungen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kolorektale Neubildungen
- Darmtumoren
- Rektale Erkrankungen
- Rektale Neoplasien
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Epidemiologische Messungen
- Ernährungsbewertung
Andere Studien-ID-Nummern
- 2021.028
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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