Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-10 @ 2:48 PM
Study NCT ID:
NCT03206866
Status:
UNKNOWN
Last Update Posted:
2017-07-02
First Post:
2017-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum regucalcin in HCC patients', 'timeFrame': '1-12-2016 to 1-12-2017', 'description': "This work aims to assess serum regucalcin antibodies level using ELISA in HCC patients to:\n\n* evaluate its potential role as biomarker in diagnosis.\n* evaluate potential associations of the presence of serum regucalcin antibody with HCC patients' clinico-epidemiological parameters."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Role of Serum Regucalcin in Diagnosis of HCC']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ocmu.mans.edu.eg/en/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets.\n\nSMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identiļ¬ed from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens \\[4\\]\n\nSerum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients will be subjected to the following:\n\n* Detailed History taking.\n* Physical examination.\n* Routine laboratory investigations essential for diagnosis and follow up of patients including:\n\n 1. Complete blood count (CBC).\n 2. Chemistry profile: serum bilirubin-serum albumin-SGPT-SGOT.\n 3. serum regucalcin(SMP30) antibodies using ELISA\n 4. AFP level.\n* Radiological assessment:\n\nUS, Triphasic CT to assess (tumor site, size, numbers, nodal metastases, distal metastases, portal vein invasion..)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy)\n2. Adult patients\n3. Both genders are eligible.\n4. Informed consent obtained from subject or subject's legal representative\n\nExclusion Criteria:\n\n1. Patient with other malignancies.\n2. Patients with advanced comorbidities except for renal failure.\n3. Prior chemotherapy"}, 'identificationModule': {'nctId': 'NCT03206866', 'briefTitle': 'Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SMP30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with HCC', 'interventionNames': ['Diagnostic Test: serum regucalcin antibody']}, {'label': 'patients with hepatitis C Ab positive', 'interventionNames': ['Diagnostic Test: serum regucalcin antibody']}, {'label': 'patients with hepatitis C Ab negative', 'interventionNames': ['Diagnostic Test: serum regucalcin antibody']}], 'interventions': [{'name': 'serum regucalcin antibody', 'type': 'DIAGNOSTIC_TEST', 'description': 'serum regucalcin antibody', 'armGroupLabels': ['patients with HCC', 'patients with hepatitis C Ab negative', 'patients with hepatitis C Ab positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'maha zaafarany, professor', 'role': 'CONTACT', 'phone': '01001996798'}, {'name': 'sameh samaa, professor', 'role': 'CONTACT', 'phone': '01001009510'}], 'facility': 'Oncology Center Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical oncology resident', 'investigatorFullName': 'Ahmed_Elalfy', 'investigatorAffiliation': 'Mansoura University'}}}}