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Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03385213
Enrollment
200
Registered
2017-12-28
Start date
2016-05-01
Completion date
2022-12-01
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gut Microbiota

Keywords

Microbiota, colorectal cancer, relapse, surveillance

Brief summary

Colonic microbiome has been found to contribute to the development of colorectal cancer. We speculate that gut microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of gut microbiota exist in patients who suffer from cancer relapse compared with patients who do not. Finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Detailed description

Treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV colorectal cancer develop recurrent disease. The human colon plays host to a diverse and metabolically complex community of microorganisms. While the colonic microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that gut microbiota related to colorectal cancer relapse after curative treatment. Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of gut microbiota is exist in patients who suffer from relapse compared with patients who do not. Future surveillance after colorectal cancer treatment should focus on risk-stratification and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Interventions

None listed

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Requirements of informed consent and assent of participant, parent or legal guardian as applicable * Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 and 75 years old without considering sex. * Patients with BMI= 18.5-23.9 * Participants can follow the visit plan

Exclusion criteria

* Patients with colorectal cancer with distant metastasis * Chronic renal diseases and hepatic cirrhosis * Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months * Individuals with a history of Chronic diarrhea * Individuals with a history of Diabetes mellitus * Individuals with a history of Hypertension * Individuals with a history of autoimmune diseases * Use of antibiotics and probiotics 3 mouth before samples collection * Individuals with a history of abdominal operation due to any reason * Individuals with any history of cancer other than colorectal cancer * Individuals with Inflammatory bowel disease

Design outcomes

Primary

MeasureTime frameDescription
Transcriptional changes in gut microbiotaBaseline, 6 months after surgery, 12 months after surgery, 24 months after surgery16S rRNA gene sequencing will be performed with stander procedure

Secondary

MeasureTime frameDescription
Epigenetic changesBaseline, 6 months after surgery, 12 months after surgery, 24 months after surgeryDNA methylation levels are analysed at baseline and after probiotics use in tissue samples

Countries

China

Contacts

Primary ContactYunwei Wei
hydwyw11@hotmail.com+86045185553099
Backup ContactYang Liu
+8618345180169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026