Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 6:40 PM
Study NCT ID:
NCT05204433
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between SFRP1 and Colorectal Cancer and Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness of methylation markers from stool samples', 'timeFrame': '3 years', 'description': 'assess the effectiveness of methylation markers from stool samples in colon cancer patients, colorectal adenoma patients, compared with normal volunteers'}], 'secondaryOutcomes': [{'measure': 'assess the capacities of RF model in screening potential clinical biomarkers.', 'timeFrame': '3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Diagnosis of Colorectal Cancer and Adenoma']}, 'descriptionModule': {'briefSummary': 'In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1\\_16\\_17\\_18 CpG site was good performance as a diagnostic marker of colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive adult patients undergoing an outpatient endoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.\n\nExclusion Criteria:\n\n* Lynch syndrome\n* Familial adenomatous polyposis\n* MUTYH associated polyposis\n* Peutz-Jeghers syndrome\n* Juvenile polyposis syndrome\n* Serrated polyposis syndrome'}, 'identificationModule': {'nctId': 'NCT05204433', 'briefTitle': 'Correlation Between SFRP1 and Colorectal Cancer and Adenoma', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Correlation Between Methylation Site of SFRP1 Gene Promoter and Colorectal Cancer and Adenoma', 'orgStudyIdInfo': {'id': 'XJLJ-Fecal-adenoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal control', 'description': 'healthy volunteers', 'interventionNames': ['Other: no intervention']}, {'label': 'adenoma', 'description': 'pathologically reported colorectal adenoma', 'interventionNames': ['Other: no intervention']}, {'label': 'colorectcal cancer', 'description': 'pathologically reported colon cancers', 'interventionNames': ['Other: no intervention']}, {'label': 'High risk group', 'description': 'pathologically reported inflammatory bowel diseases'}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['adenoma', 'colorectcal cancer', 'normal control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710012', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Jie Liang', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jie Liang', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}