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This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murdani Abdullah | Contact | +628129550812 | kolitgastro@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Murdani Abdullah | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) | Jakarta | DKI Jakarta | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2019 | Jul 4, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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.
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| Fecal sampling | Diagnostic Test | Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome.
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |