Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse
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|ClinicalTrials.gov Identifier: NCT03385213|
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : May 9, 2018
|Condition or disease|
|Gut Microbiota Colorectal Cancer|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery|
|Actual Study Start Date :||May 1, 2016|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2022|
Patients who suffered colorectal cancer relapse after curative surgery
Patients who get remission after curative surgery
- Transcriptional changes in gut microbiota [ Time Frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery ]16S rRNA gene sequencing will be performed with stander procedure
- Epigenetic changes [ Time Frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery ]DNA methylation levels are analysed at baseline and after probiotics use in tissue samples
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385213
|Contact: Yunwei Weiemail@example.com|
|Contact: Yang Liu||+8618345180169|
|Harbin, Heilongjiang, China, 150001|
|Contact: Yunwei Wei firstname.lastname@example.org|
|Study Director:||Yunwei Wei||First Affiliated Hospital of Harbin Medical University|