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Trial record 21 of 4082 for:    colon cancer AND Intestinal Neoplasms

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

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ClinicalTrials.gov Identifier: NCT04011969
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia

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

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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

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): NCT04011969


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) Not yet recruiting
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
  Study Documents (Full-Text)

Documents provided by Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia:
Study Protocol  [PDF] April 24, 2019


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Responsible Party: Murdani Abdullah, Professor, Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT04011969     History of Changes
Other Study ID Numbers: 19-05-0528
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia:
chronic inflammation
young-onset colorectal cancer
gut microbiome
NGS

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Inflammation
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Pathologic Processes