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Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer (BIORECTUM)

5. juni 2026 opdateret af: Antoni Codina Cazador, PhD, MD, University Hospital of Girona Dr. Josep Trueta

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
    • Girona
      • Girona, Girona, Spanien, 17007
        • Rekruttering
        • Hospital Universitari Dr. Josep Trueta de Girona
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 18 år (Voksen)

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients diagnosed with rectal cancer

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Procedure: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedure: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedure: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Adfærdsmæssigt: 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.
Procedure: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedure: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedure: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Adfærdsmæssigt: 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.
Procedure: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedure: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedure: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Adfærdsmæssigt: Dietary assessment
Dietary assessment will be taken at baseline
Control group
Patients diagnosed with non-oncological disease
Procedure: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedure: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Adfærdsmæssigt: Dietary assessment
Dietary assessment will be taken at baseline
Patients diagnosed with colon cancer
Patients diagnosed with colon cancer who require elective surgery.
Procedure: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedure: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedure: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Adfærdsmæssigt: Dietary assessment
Dietary assessment will be taken at baseline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Tidsramme: Up to 5 years after rectal cancer surgery
Correlation between mesorectal microbial and metabolomic signatures and survival
Up to 5 years after rectal cancer surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation
Tidsramme: 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
Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis
Tidsramme: 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
Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response
Tidsramme: Up to 1 month after rectal cancer surgery
Correlation between adipose tissue, fecal and rectal mucosa dysfunction and response to neoadjuvant treatment
Up to 1 month after rectal cancer surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital of Girona Dr. Josep Trueta

Samarbejdspartnere

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2021

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

15. marts 2021

Først indsendt, der opfyldte QC-kriterier

15. marts 2021

Først opslået (Faktiske)

18. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021.028

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