Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT07143435
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2025-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Findings in Iron Deficiency Anemia: A Cross-Sectional Study From Port Sudan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with endoscopic lesions explaining iron deficiency anemia', 'timeFrame': '4 months', 'description': 'Percentage of participants with one or more endoscopic findings potentially accounting for IDA (e.g., gastric/duodenal ulcer, gastritis with bleeding, colonic mass/ulcer, angiodysplasia), confirmed by endoscopy ± biopsy when indicated.'}], 'secondaryOutcomes': [{'measure': 'Proportion of biopsy-proven malignancies', 'timeFrame': '4 months', 'description': 'Percentage of participants with histopathology-confirmed gastrointestinal malignancy (e.g., gastric adenocarcinoma, colorectal cancer).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sudan', 'Gastrointestinal blood loss', 'Endoscopic findings'], 'conditions': ['Iron Deficiency Anemia', 'Endoscopy', 'Anemia']}, 'descriptionModule': {'briefSummary': 'Background: Iron deficiency anemia (IDA) is a common condition often linked to gastrointestinal blood loss, making endoscopic evaluation essential for identifying underlying causes. This study aimed to assess the endoscopic findings in patients presenting with IDA in Red Sea State, Sudan. Understanding the prevalence and types of gastrointestinal lesions among these patients can aid in early diagnosis and management, reducing associated morbidity and mortality. By focusing on patients undergoing endoscopic evaluation, this study provides valuable insights into the burden of gastrointestinal pathologies contributing to IDA in the region.\n\nMaterials and Methods: This cross-sectional, descriptive study was conducted in the Endoscopy Unit at Alkaleej Medical Complex - Portsudan. Adults aged ≥18 years with IDA undergoing endoscopic evaluation were included, excluding those unwilling participation or with incomplete data. Data were collected via structured questionnaires and medical records, covering demographics, medical history, clinical presentation, and endoscopic findings. SPSS version 26 - 2018, was used for analysis, applying descriptive statistics and chi-square tests to assess associations. Ethical approval was obtained, and informed consent was secured from all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of all patients presenting with IDA who underwent endoscopic evaluation at the study site during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and above.\n* Patients diagnosed with IDA who underwent endoscopic evaluation.\n\nExclusion Criteria:\n\n* Patients who declined to participate in the study.\n* Patients with incomplete medical records or missing endoscopic findings.'}, 'identificationModule': {'nctId': 'NCT07143435', 'acronym': 'IDA', 'briefTitle': 'Endoscopic Findings in Iron Deficiency Anemia: A Cross-Sectional Study From Port Sudan', 'organization': {'class': 'OTHER', 'fullName': 'National Center for Gastroentestinal and Liver Disease'}, 'officialTitle': 'Endoscopic Findings in Iron Deficiency Anemia: A Cross-Sectional Study From Port Sudan', 'orgStudyIdInfo': {'id': 'EndoscopicFindingsIronDef'}}, 'contactsLocationsModule': {'locations': [{'zip': '21111', 'city': 'Kassala', 'country': 'Sudan', 'facility': 'Alkhaleej Medical Center', 'geoPoint': {'lat': 15.45099, 'lon': 36.39998}}], 'overallOfficials': [{'name': 'Mohammed Ganim, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center for Gastrointestinal And Liver Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Gastroentestinal and Liver Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}