Gut Microbiota Prediction of Metachronous Colorectal Neoplasms
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|ClinicalTrials.gov Identifier: NCT03383159|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : June 27, 2018
|Condition or disease|
|Gut Microbiota Metachronous Adenoma|
Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.
Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.
The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.
This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer|
|Actual Study Start Date :||May 1, 2016|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Observation group 1
Patients who suffered metachronous adenoma after proximal colorectum cancer surgery.
Control group 1
Patients who do not suffere metachronous adenoma after proximal colorectum cancer surgery.
Observation group 2
Patients who suffered metachronous adenoma after distal colorectum cancer surgery.
Control group 2
Patients who do not suffered metachronous adenoma after distal colorectum cancer surgery.
- Differences In Microbiota [ Time Frame: 1, 3 and 5 years after surgery ]The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.
- Predictive model establish [ Time Frame: June to August of 2018 ]Using microbita construct a predictive model of postoperative colorectal neoplasm development.
- Predictive model validation [ Time Frame: August of 2018 to April of 2019 ]Validation the accuracy of the predictive model.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383159
|Contact: Yunwei Weiemail@example.com|
|Contact: Ye Jinfirstname.lastname@example.org|
|First affiliated hospital of Harbin medical university||Recruiting|
|Harbin, Heilongjiang, China, 150001|
|Contact: Yunwei Wei +86-0451-85553099 email@example.com|
|Principal Investigator:||Yunwei Wei||First Affiliated Hospital of Harbin Medical University|