Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT07236333
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of CALLY and HAALP in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Patients' HALP Score", 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Ulcerative colitis patients will be evaluated by evaluating the Change in HALP Score and its effect on prognosis.'}, {'measure': "Change in Patients' CALLY Index Score", 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Ulcerative colitis patients will be evaluated by evaluating the Change in CALLY Index Score and its effect on prognosis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'CALLY', 'HAALP'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://doi.org/10.1007/S00384-021-04009-2', 'label': '1\\. Further research on the clinical relevance of the ulcerative colitis colonoscopic index of severity for predicting 5-year relapse'}, {'url': 'http://doi.org/10.1016/J.RGMXEN.2019.02.006', 'label': '2\\. Validation of a novel integral disease index for evaluating the grade of activity in Mexican patients with ulcerative colitis: A prospective cohort study'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the type and amount of retention in the colon during ulcerative colitis activation, as well as the relationship between C-reactive protein (CRP), albumin and the calculated CALLY index. The investigators also aim to establish whether this ratio can be used to indicate activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ulserative colitis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* under 18\n\nExclusion Criteria:\n\n* no UC'}, 'identificationModule': {'nctId': 'NCT07236333', 'briefTitle': 'The Role of CALLY and HAALP in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Role of CALLY and HAALP Scores in the Evaluation of Ulcerative Colitis Attack', 'orgStudyIdInfo': {'id': 'ZTKLAB30012025TBAEK121GASTROEN'}, 'secondaryIdInfos': [{'id': 'TBAEK-121', 'type': 'OTHER', 'domain': 'Akdeniz University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CALLY', 'type': 'DIAGNOSTIC_TEST', 'description': 'The CALLY index, integrating C-reactive protein (CRP), albumin, and lymphocyte count, has been identified as a promising prognostic biomarker.'}, {'name': 'HALP', 'type': 'DIAGNOSTIC_TEST', 'description': 'The HALP score is calculated as HALP Score = \\[hemoglobin (g/L) × albumin (g/L) × lymphocytes (/L)\\]/platelets (/L). It is a definitive biomarker.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07030', 'city': 'Antalya', 'state': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Akdeniz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'okkes zortuk', 'investigatorAffiliation': 'Ataturk University'}}}}