Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 7:36 AM
Study NCT ID:
NCT05593068
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012806', 'term': 'Siderosis'}], 'ancestors': [{'id': 'D011009', 'term': 'Pneumoconiosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of pancreatic iron deposit', 'timeFrame': '1 day', 'description': 'Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2\\* value in ms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deposition', 'Dialysis', 'Iatrogenic Hemosiderosis']}, 'referencesModule': {'references': [{'pmid': '41215782', 'type': 'DERIVED', 'citation': 'Rostoker G, Griuncelli M, Francisco S, Loridon C, Languille-Llitjos E, Boulahia G, Cohen Y. Evidence of pancreatic iron deposits and their association with mortality in dialysis-associated iatrogenic hemosiderosis. Clin Kidney J. 2025 Oct 6;18(11):sfaf309. doi: 10.1093/ckj/sfaf309. eCollection 2025 Nov.'}]}, 'descriptionModule': {'briefSummary': 'Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.\n\nIn this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2\\* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient on hemodialysis or peritoneal dialysis at Claude Galien Private Hospital. They had to perform an MRI for iron quantification', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, female, over 18 years old\n* Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital\n* Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification\n* Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study\n\nExclusion Criteria:\n\n* Patient who has signed a form to object to the use of their health data\n* Pregnant woman\n* Poor adherence to the dialytic technique\n* Severe cognitive impairment\n* Hepatic cirrhosis\n* Frank inflammatory syndrome or an active infectious disease\n* Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases\n* Recent major bleeding (\\< 3 months)\n* Recent major surgery (\\< 3 months)\n* Transfusion dependence\n* Progressive malignant disease\n* Pacemakers incompatible with an MRI and metal heart valves'}, 'identificationModule': {'nctId': 'NCT05593068', 'acronym': 'ERDFP', 'briefTitle': 'Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic', 'orgStudyIdInfo': {'id': 'ERDFP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dialysed patients with suspicion of hepatic iron', 'description': 'Patients on dialysis at Claude Galien Private Hospital who had one or more MRI scans to monitor possible hepatic iron overload between May 2012 and March 2018.', 'interventionNames': ['Procedure: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'description': 'Pancreatic MRI', 'armGroupLabels': ['Dialysed patients with suspicion of hepatic iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91480', 'city': 'Quincy-sous-Sénart', 'country': 'France', 'contacts': [{'name': 'Guy ROSTOKER, Dr', 'role': 'CONTACT', 'email': 'rostotom@orange.fr', 'phone': '06 03 00 42 91'}], 'facility': 'Hôpital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}], 'centralContacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jeanfrancois.oudet@free.fr', 'phone': '0683346567'}, {'name': 'Marie-Hélène Barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}