Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-19 @ 7:58 AM
Study NCT ID:
NCT04831632
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 630}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic performance', 'timeFrame': '2 years', 'description': 'To determine the diagnostic performance of the quantitative iFOBT with various cut-off points and the qualitative iFOBT, compared to the VCC, when detecting advanced colon neoplasms.'}], 'secondaryOutcomes': [{'measure': 'qualitative iFOBT positivity rate', 'timeFrame': '2 years', 'description': 'To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'colorectal cancer', 'fecal immunochemical test', 'FIT accuracy'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': "In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "people who belong to Hospital El Cruce's coverage area", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* men and women aged 50-75\n* Hospital El Cruce's coverage area and\n\nExclusion Criteria:\n\n* those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment\n* personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60\n* those refuse to sign the consent form to take part in this study"}, 'identificationModule': {'nctId': 'NCT04831632', 'briefTitle': 'Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic', 'organization': {'class': 'OTHER', 'fullName': 'Hospital El Cruce'}, 'officialTitle': 'Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort', 'orgStudyIdInfo': {'id': '091/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'people aged 50-75', 'description': "men and women aged 50-75 who belong to Hospital El Cruce's coverage area and do not have personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60", 'interventionNames': ['Diagnostic Test: quantitative and qualitative iFOBTs']}], 'interventions': [{'name': 'quantitative and qualitative iFOBTs', 'type': 'DIAGNOSTIC_TEST', 'description': "They will have their qualitative and quantitative iFOBTs done within the week prior to the VCC study completion. The reading of both of them will be done in Hospital El Cruce's laboratory. The result of the qualitative iFOBT will have two valid expressions: positive or negative.The result of the quantitative iFOBT will be expressed as µg from hemoglobin per gram of fecal matter through the use of automatized equipment for laboratory analysis.", 'armGroupLabels': ['people aged 50-75']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1888', 'city': 'San Juan Bautista', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital El Cruce', 'geoPoint': {'lat': -34.80896, 'lon': -58.27623}}], 'centralContacts': [{'name': 'Raúl Matanó, Doctor', 'role': 'CONTACT', 'email': 'raulfmatano@hotmail.com', 'phone': '5492214203306'}, {'name': 'Cecilia Curvale, Doctor', 'role': 'CONTACT', 'email': 'cecicurvale@hotmail.com', 'phone': '5491140878193'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CECILIA CURVALE', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Public Health, Argentina', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator', 'investigatorFullName': 'CECILIA CURVALE', 'investigatorAffiliation': 'Hospital El Cruce'}}}}