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

Colorectal Cancer Clinical Trial

Official title:

The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04011969
• Other study ID #: 19-05-0528
• Status: Not yet recruiting
• Start date: July 2019
• Est. completion date: May 2022

Study information

• Verified date: July 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Murdani Abdullah
• Phone: +628129550812
• Email: kolitgastro[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammation

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.
• 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-?B by immunohistochemical method. 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-?B 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. 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. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.

Locations

Country	Name	City	State
Indonesia	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiome	Gut microbiome examination will be conducted with next generation sequencing (NGS) method	pre-colonoscopy, approximately 1 day before colonoscopy
Primary	Asia Pacific Colorectal Screening (APCS) score	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	pre-colonoscopy, approximately 1 day before colonoscopy
Primary	Carcinoembryonic antigen (CEA) serum level	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.	pre-colonoscopy, approximately 1 day before colonoscopy
Primary	Presence of NF-?B	NF-?B is a chronic inflammation marker found in colorectal cancer patients. Presence of NF-?B is assessed with immunohistochemical method. The result is considered positive if accumulated score = 3.	pre-colonoscopy, approximately 1 day before colonoscopy
Primary	Fecal immunochemical test (FIT)	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	pre-colonoscopy, approximately 1 day before colonoscopy