Rectal CancerBIORECTUMNCT04804956
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer
An observational study of Rectal Cancer, run by University Hospital of Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Stool sample, Rectal mucosa sample and Mesorectal adipose tissue sample
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- Adult
Study population: Patients diagnosed with rectal cancer
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, 17007
Antoni Codina, MD, PhD, 972940256, acodinac.girona.ics@gencat.cat
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Rectal Cancer
- Being tested
- Stool sample, Rectal mucosa sample, Mesorectal adipose tissue sample, Subcutaneous adipose tissue sample, Visceral adipose tissue sample
- Keywords
- Rectal Neoplasms, Colorectal surgery, Gastrointestinal Microbiome, Metabolomics, Microbiome
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleProcedure or surgery
One stool sample will be taken at baseline for microbiota characterization
Rectal mucosa sampleProcedure or surgery
Characterization of tissue microbiota before and after surgery.
Mesorectal adipose tissue sampleProcedure or surgery
Characterization of tissue microbiota and dysfunction
Subcutaneous adipose tissue sampleProcedure or surgery
Characterization of tissue microbiota and dysfunction
Visceral adipose tissue sampleProcedure or surgery
Characterization of tissue microbiota and dysfunction
Dietary assessmentBehavioural
Dietary assessment will be taken at baseline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stool sample; Procedure: Rectal mucosa sample; Procedure: Mesorectal adipose tissue sample; Procedure: Subcutaneous adipose tissue sample; Procedure: Visceral adipose tissue sample; Behavioral: Dietary assessment | |
| 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. Receives: Procedure: Stool sample; Procedure: Rectal mucosa sample; Procedure: Mesorectal adipose tissue sample; Procedure: Subcutaneous adipose tissue sample; Procedure: Visceral adipose tissue sample; Behavioral: Dietary assessment | |
| 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. Receives: Procedure: Stool sample; Procedure: Rectal mucosa sample; Procedure: Mesorectal adipose tissue sample; Procedure: Subcutaneous adipose tissue sample; Procedure: Visceral adipose tissue sample; Behavioral: Dietary assessment | |
| Control group | Patients diagnosed with non-oncological disease Receives: Procedure: Stool sample; Procedure: Subcutaneous adipose tissue sample; Procedure: Visceral adipose tissue sample; Behavioral: Dietary assessment | |
| Patients diagnosed with colon cancer | Patients diagnosed with colon cancer who require elective surgery. Receives: Procedure: Stool sample; Procedure: Subcutaneous adipose tissue sample; Procedure: Visceral adipose tissue sample; Behavioral: Dietary assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Correlation between mesorectal microbial and metabolomic signatures and survival
Measured: Up to 5 years after rectal cancer surgery
Secondary outcomes (3)
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
Measured: Up to 1 month after rectal cancer surgery
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
Measured: 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
Measured: Up to 1 month after rectal cancer surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Girona Dr. Josep Trueta
- Sponsor type
- Research network
- Collaborators
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Responsible party
- Principal investigator, Antoni Codina Cazador, PhD, MD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804956
- Sponsor's protocol ID
- 2021.028
- Acronym
- BIORECTUM
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2021
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer and Analysis of it's Applicability in Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT04804956
- Acronym / sponsor ID
- BIORECTUM / 2021.028
- Conditions
- Rectal Cancer
- Keywords
- Rectal Neoplasms, Colorectal surgery, Gastrointestinal Microbiome, Metabolomics, Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of Girona Dr. Josep TruetaResearch network
- Collaborators
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Early-rectal cancer | – | Procedure: Stool sample, Procedure: Rectal mucosa sample, Procedure: Mesorectal adipose tissue sample, Procedure: Subcutaneous adipose tissue sample, Procedure: Visceral adipose tissue sample, Behavioral: Dietary assessmentThe 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. |
| Advanced-rectal cancer | – | Procedure: Stool sample, Procedure: Rectal mucosa sample, Procedure: Mesorectal adipose tissue sample, Procedure: Subcutaneous adipose tissue sample, Procedure: Visceral adipose tissue sample, Behavioral: Dietary assessmentThe 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. |
| Synchronous metastasis -rectal cancer | – | Procedure: Stool sample, Procedure: Rectal mucosa sample, Procedure: Mesorectal adipose tissue sample, Procedure: Subcutaneous adipose tissue sample, Procedure: Visceral adipose tissue sample, Behavioral: Dietary assessmentThe 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. |
| Control group | – | Procedure: Stool sample, Procedure: Subcutaneous adipose tissue sample, Procedure: Visceral adipose tissue sample, Behavioral: Dietary assessmentPatients diagnosed with non-oncological disease |
| Patients diagnosed with colon cancer | – | Procedure: Stool sample, Procedure: Subcutaneous adipose tissue sample, Procedure: Visceral adipose tissue sample, Behavioral: Dietary assessmentPatients diagnosed with colon cancer who require elective surgery. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients diagnosed with rectal cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool sampleOne stool sample will be taken at baseline for microbiota characterization | Procedure or surgery | Advanced-rectal cancer, Control group, Early-rectal cancer, Patients diagnosed with colon cancer, Synchronous metastasis -rectal cancer |
| Rectal mucosa sampleCharacterization of tissue microbiota before and after surgery. | Procedure or surgery | Advanced-rectal cancer, Early-rectal cancer, Synchronous metastasis -rectal cancer |
| Mesorectal adipose tissue sampleCharacterization of tissue microbiota and dysfunction | Procedure or surgery | Advanced-rectal cancer, Early-rectal cancer, Synchronous metastasis -rectal cancer |
| Subcutaneous adipose tissue sampleCharacterization of tissue microbiota and dysfunction | Procedure or surgery | Advanced-rectal cancer, Control group, Early-rectal cancer, Patients diagnosed with colon cancer, Synchronous metastasis -rectal cancer |
| Visceral adipose tissue sampleCharacterization of tissue microbiota and dysfunction | Procedure or surgery | Advanced-rectal cancer, Control group, Early-rectal cancer, Patients diagnosed with colon cancer, Synchronous metastasis -rectal cancer |
| Dietary assessmentDietary assessment will be taken at baseline | Behavioural | Advanced-rectal cancer, Control group, Early-rectal cancer, Patients diagnosed with colon cancer, Synchronous metastasis -rectal cancer |
Primary outcome
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Time frame: Up to 5 years after rectal cancer surgery
Correlation between mesorectal microbial and metabolomic signatures and survival
3 secondary outcomes
Adipose tissue, fecal and rectal mucosa microbiome and metabolome characterisation
Time frame: Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa metabolomic dysfunctionality and its correlation with microbial dysbiosis
Time frame: Up to 1 month after rectal cancer surgery
Adipose tissue, fecal and rectal mucosa dysfunctionality and dysbiosis on tumor progression and response
Time frame: Up to 1 month after rectal cancer surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University Hospital of Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoni Codina Cazador, MD, PhD (+34972940256, acodinac.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer (time frame: Up to 5 years after rectal cancer surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.