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

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
    • Girona
      • Girona, Girona, Spagna, 17007
        • Reclutamento
        • Hospital Universitari Dr. Josep Trueta de Girona
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 18 anni (Adulto)

Accetta volontari sani

N/A

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Patients diagnosed with rectal cancer

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Procedura: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedura: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedura: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Comportamentale: 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.
Procedura: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedura: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedura: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Comportamentale: 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.
Procedura: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedura: Rectal mucosa sample
Characterization of tissue microbiota before and after surgery.
Procedura: Mesorectal adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Comportamentale: Dietary assessment
Dietary assessment will be taken at baseline
Control group
Patients diagnosed with non-oncological disease
Procedura: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedura: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Comportamentale: Dietary assessment
Dietary assessment will be taken at baseline
Patients diagnosed with colon cancer
Patients diagnosed with colon cancer who require elective surgery.
Procedura: Stool sample
One stool sample will be taken at baseline for microbiota characterization
Procedura: Subcutaneous adipose tissue sample
Characterization of tissue microbiota and dysfunction
Procedura: Visceral adipose tissue sample
Characterization of tissue microbiota and dysfunction
Comportamentale: Dietary assessment
Dietary assessment will be taken at baseline

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital of Girona Dr. Josep Trueta

Collaboratori

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2021

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

15 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

15 marzo 2021

Primo Inserito (Effettivo)

18 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021.028

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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