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

NCT04011969 | Unknown

• 1 other identifier: 19-05-0528
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

chronic inflammation; young-onset colorectal cancer; gut microbiome; NGS

Outcome Measures

Primary Outcomes (5)

• Gut microbiome

  Gut microbiome examination will be conducted with next generation sequencing (NGS) method

  pre-colonoscopy, approximately 1 day before colonoscopy

• 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

• 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

• Presence of NF-ҡB

  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.

  pre-colonoscopy, approximately 1 day before colonoscopy

• 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

Study Arms (1)

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; Diagnostic Test: Blood sampling; Diagnostic Test: Fecal sampling

Interventions

Score assessment DIAGNOSTIC_TEST

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.

Colorectal cancer suspects

Blood sampling DIAGNOSTIC_TEST

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.

Colorectal cancer suspects

Fecal sampling DIAGNOSTIC_TEST

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.

Colorectal cancer suspects

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age ≥ 35 years old
• Suspected with colorectal cancer and undergoing a colonoscopy procedure
• No history of colorectal cancer treatment

You may not qualify if:

• Unwilling to provide fecal and blood sample
• Incomplete colonoscopy procedure due to any reasons

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Murdani Abdullah

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murdani Abdullah

CONTACT

+628129550812; kolitgastro@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: July 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

ID (1)