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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorUniversity Hospital of Girona Dr. Josep Trueta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients diagnosed with rectal cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Stool sample

    Procedure/Surgery

    One stool sample will be taken at baseline for microbiota characterization

  • Rectal mucosa sample

    Procedure/Surgery

    Characterization of tissue microbiota before and after surgery.

  • Mesorectal adipose tissue sample

    Procedure/Surgery

    Characterization of tissue microbiota and dysfunction

  • Subcutaneous adipose tissue sample

    Procedure/Surgery

    Characterization of tissue microbiota and dysfunction

  • Visceral adipose tissue sample

    Procedure/Surgery

    Characterization of tissue microbiota and dysfunction

  • Dietary assessment

    Behavioral

    Dietary assessment will be taken at baseline

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: Early-rectal cancer6 interventions
Group B: Advanced-rectal cancer6 interventions
Group C: Synchronous metastasis -rectal cancer6 interventions
Group D: Control group4 interventions
Group E: Patients diagnosed with colon cancer4 interventions

Trial outcomes

Primary outcomes

1

Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer

Correlation between mesorectal microbial and metabolomic signatures and survival

Time frame
Up to 5 years after rectal cancer surgery

Secondary outcomes

1

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

Time frame
Up to 1 month after rectal cancer surgery
2

Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis

Analysis of adipose tissue, fecal and rectal mucosa dysfunctionality tissue inflammation, angiogenesis and hypoxia and its correlation with microbial dysbiosis

Time frame
Up to 1 month after rectal cancer surgery
3

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

Time frame
Up to 1 month after rectal cancer surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Girona Dr. Josep Trueta

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Sponsor institution

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Collaborator

Source ClinicalTrials.gov
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