Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04011969
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-24', 'size': 464954, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-04T00:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiome', 'timeFrame': 'pre-colonoscopy, approximately 1 day before colonoscopy', 'description': 'Gut microbiome examination will be conducted with next generation sequencing (NGS) method'}, {'measure': 'Asia Pacific Colorectal Screening (APCS) score', 'timeFrame': 'pre-colonoscopy, approximately 1 day before colonoscopy', 'description': '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': 'Carcinoembryonic antigen (CEA) serum level', 'timeFrame': 'pre-colonoscopy, approximately 1 day before colonoscopy', 'description': '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.'}, {'measure': 'Presence of NF-ҡB', 'timeFrame': 'pre-colonoscopy, approximately 1 day before colonoscopy', 'description': '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.'}, {'measure': 'Fecal immunochemical test (FIT)', 'timeFrame': 'pre-colonoscopy, approximately 1 day before colonoscopy', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic inflammation', 'young-onset colorectal cancer', 'gut microbiome', 'NGS'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 35 years old\n2. Suspected with colorectal cancer and undergoing a colonoscopy procedure\n3. No history of colorectal cancer treatment\n\nExclusion Criteria:\n\n1. Unwilling to provide fecal and blood sample\n2. Incomplete colonoscopy procedure due to any reasons'}, 'identificationModule': {'nctId': 'NCT04011969', 'briefTitle': 'The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fakultas Kedokteran Universitas Indonesia'}, 'officialTitle': 'The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method', 'orgStudyIdInfo': {'id': '19-05-0528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal cancer suspects', 'description': '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.', 'interventionNames': ['Diagnostic Test: Score assessment', 'Diagnostic Test: Blood sampling', 'Diagnostic Test: Fecal sampling']}], 'interventions': [{'name': 'Score assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Colorectal cancer suspects']}, {'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\n1. 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.\n2. NF-ҡB is a chronic inflammation marker found in colorectal cancer patients.', 'armGroupLabels': ['Colorectal cancer suspects']}, {'name': 'Fecal sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome.\n\n1. 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.\n2. Gut microbiome examination will be conducted with next generation sequencing (NGS) method.', 'armGroupLabels': ['Colorectal cancer suspects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'contacts': [{'name': 'Murdani Abdullah', 'role': 'CONTACT'}], 'facility': 'RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Murdani Abdullah', 'role': 'CONTACT', 'email': 'kolitgastro@gmail.com', 'phone': '+628129550812'}], 'overallOfficials': [{'name': 'Murdani Abdullah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Murdani Abdullah', 'investigatorAffiliation': 'Fakultas Kedokteran Universitas Indonesia'}}}}