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出境医 / 临床实验 / The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer

The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer

Study Description
Brief Summary:
This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: Score assessment Diagnostic Test: Blood sampling Diagnostic Test: Fecal sampling

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
Group/Cohort Intervention/treatment
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.
 Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.
Outcome Measures
Primary Outcome Measures :
  1. Gut microbiome [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    Gut microbiome examination will be conducted with next generation sequencing (NGS) method

  2. Asia Pacific Colorectal Screening (APCS) score [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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

  3. Carcinoembryonic antigen (CEA) serum level [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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.

  4. Presence of NF-ҡB [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    NF-ҡB is a chronic inflammation marker found in colorectal cancer patients. Presence of NF-ҡB is assessed with immunohistochemical method. The result is considered positive if accumulated score ≥ 3.

  5. Fecal immunochemical test (FIT) [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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. Since this is a pilot study to obtain gut microbiome pattern on colorectal cancer patients, the number of samples is determined by the researchers: 100 subjects for neoplasm and 50 subjects for non-neoplasm (according to histopathology report)
Criteria

Inclusion Criteria:

  1. Age ≥ 35 years old
  2. Suspected with colorectal cancer and undergoing a colonoscopy procedure
  3. No history of colorectal cancer treatment

Exclusion Criteria:

  1. Unwilling to provide fecal and blood sample
  2. Incomplete colonoscopy procedure due to any reasons
Contacts and Locations

Contacts
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Contact: Murdani Abdullah +628129550812 kolitgastro@gmail.com

Locations
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Indonesia
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, DKI Jakarta, Indonesia, 10430
Contact: Murdani Abdullah         
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
Investigators
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Principal Investigator: Murdani Abdullah Fakultas Kedokteran Universitas Indonesia
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 9, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
  • Gut microbiome [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    Gut microbiome examination will be conducted with next generation sequencing (NGS) method
  • Asia Pacific Colorectal Screening (APCS) score [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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
  • Carcinoembryonic antigen (CEA) serum level [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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.
  • Presence of NF-ҡB [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    NF-ҡB is a chronic inflammation marker found in colorectal cancer patients. Presence of NF-ҡB is assessed with immunohistochemical method. The result is considered positive if accumulated score ≥ 3.
  • Fecal immunochemical test (FIT) [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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
Original Primary Outcome Measures
 (submitted: July 4, 2019)
  • Gut microbiome [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    Gut microbiome examination will be conducted with next generation sequencing (NGS) method
  • Asia Pacific Colorectal Screening (APCS) score [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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
  • Carcinoembryonic antigen (CEA) serum level [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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.
  • NF-ҡB [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.
  • Fecal immunochemical test (FIT) [ Time Frame: pre-colonoscopy, approximately 1 day before colonoscopy ]
    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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer
Official Title The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method
Brief Summary This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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. Since this is a pilot study to obtain gut microbiome pattern on colorectal cancer patients, the number of samples is determined by the researchers: 100 subjects for neoplasm and 50 subjects for non-neoplasm (according to histopathology report)
Condition Colorectal Cancer
Intervention
  • Diagnostic Test: 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.
  • Diagnostic Test: 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.
  • Diagnostic Test: 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.
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Score assessment
  • Diagnostic Test: Blood sampling
  • Diagnostic Test: Fecal sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 4, 2019) 		150
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age ≥ 35 years old
  2. Suspected with colorectal cancer and undergoing a colonoscopy procedure
  3. No history of colorectal cancer treatment

Exclusion Criteria:

  1. Unwilling to provide fecal and blood sample
  2. Incomplete colonoscopy procedure due to any reasons
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Murdani Abdullah +628129550812 kolitgastro@gmail.com
Listed Location Countries Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04011969
Other Study ID Numbers 19-05-0528
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia
Study Sponsor Fakultas Kedokteran Universitas Indonesia
Collaborators Not Provided
Investigators
Principal Investigator: Murdani Abdullah Fakultas Kedokteran Universitas Indonesia
PRS Account Fakultas Kedokteran Universitas Indonesia
Verification Date July 2019

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