Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer (NCT04804956) | Clinical Trial Compass
RecruitingNot Applicable
Mesorectal Microbiome and Metabolome as a Prognostic Factor in Patients With Rectal Cancer
Spain100 participantsStarted 2021-04-01
Plain-language 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.
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.
Who can participate
Age range
18 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of mesorectal microbial and metabolomic biomarkers as prognostic factor for rectal cancer
Timeframe: Up to 5 years after rectal cancer surgery
Trial details
NCT IDNCT04804956
SponsorUniversity Hospital of Girona Dr. Josep Trueta