The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer
NCT ID: NCT04011969
Last Updated: 2019-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-07-31
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Colorectal cancer suspects
Patients suspected with colorectal cancer who come to our hospital to conduct colonoscopy procedure will be recruited for this study and will undergo a series of examinations.
Score assessment
Asia Pacific Colorectal Screening (APCS) is a validated tool to predict the risk of colorectal cancer in asymptomatic Asian population. The scoring system comprises of three categories: low risk (score 0-1), moderate risk (score 2-3) and high risk (score 4-7). Patients with moderate and high risk will undergo further examinations.
Blood sampling
Blood samples will be taken before colonoscopy procedure to evaluate the level of serum CEA by ELISA method and to evaluate the presence of NF-ҡB by immunohistochemical method.
1. Carcinoembryonic antigen (CEA) is a well-known marker for colorectal cancer. A pre-treatment serum CEA level of ≥ 5 ng/mL is associated with poor prognosis in colorectal cancer patients.
2. NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.
Fecal sampling
Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome.
1. Fecal immunochemical test (FIT) is a recommended screening method for colorectal cancer. Detection of hemoglobin over a certain level in fecal samples indicated a positive FIT. Patients with positive FIT will undergo further examinations.
2. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.
Interventions
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Score assessment
Asia Pacific Colorectal Screening (APCS) is a validated tool to predict the risk of colorectal cancer in asymptomatic Asian population. The scoring system comprises of three categories: low risk (score 0-1), moderate risk (score 2-3) and high risk (score 4-7). Patients with moderate and high risk will undergo further examinations.
Blood sampling
Blood samples will be taken before colonoscopy procedure to evaluate the level of serum CEA by ELISA method and to evaluate the presence of NF-ҡB by immunohistochemical method.
1. Carcinoembryonic antigen (CEA) is a well-known marker for colorectal cancer. A pre-treatment serum CEA level of ≥ 5 ng/mL is associated with poor prognosis in colorectal cancer patients.
2. NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.
Fecal sampling
Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome.
1. Fecal immunochemical test (FIT) is a recommended screening method for colorectal cancer. Detection of hemoglobin over a certain level in fecal samples indicated a positive FIT. Patients with positive FIT will undergo further examinations.
2. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.
Eligibility Criteria
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Inclusion Criteria
2. Suspected with colorectal cancer and undergoing a colonoscopy procedure
3. No history of colorectal cancer treatment
Exclusion Criteria
2. Incomplete colonoscopy procedure due to any reasons
35 Years
ALL
Yes
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Murdani Abdullah
Professor
Principal Investigators
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Murdani Abdullah
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Murdani Abdullah
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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19-05-0528
Identifier Type: -
Identifier Source: org_study_id
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