Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT03426358
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2018-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006504', 'term': 'Hepatic Veno-Occlusive Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development', 'timeFrame': 'From HSCT to 30 days after HSCT', 'description': 'To assess in a large, mixed (adult and paediatric) population undergoing HSCT, the role of Liver Stiffness Measurement (LSM), assessed by different elastographic methods, in SOS/VOD diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Veno Occlusive Disease', 'Sinusoidal Obstruction Syndrome', 'HSCT', 'Hematopoietic Stem Cell Transplantation', 'Stem Cell Transplant Complications', 'Liver Stiffness Measurement', 'Sinusoidal Obstructive Syndrome', 'Transient Elastography'], 'conditions': ['Veno Occlusive Disease, Hepatic', 'Sinusoidal Obstruction Syndrome', 'Stem Cell Transplant Complications']}, 'referencesModule': {'references': [{'pmid': '14564177', 'type': 'BACKGROUND', 'citation': 'Wadleigh M, Ho V, Momtaz P, Richardson P. Hepatic veno-occlusive disease: pathogenesis, diagnosis and treatment. Curr Opin Hematol. 2003 Nov;10(6):451-62. doi: 10.1097/00062752-200311000-00010.'}, {'pmid': '20373370', 'type': 'BACKGROUND', 'citation': 'McDonald GB. Hepatobiliary complications of hematopoietic cell transplantation, 40 years on. Hepatology. 2010 Apr;51(4):1450-60. doi: 10.1002/hep.23533.'}, {'pmid': '21708110', 'type': 'BACKGROUND', 'citation': 'Carreras E, Diaz-Beya M, Rosinol L, Martinez C, Fernandez-Aviles F, Rovira M. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood Marrow Transplant. 2011 Nov;17(11):1713-20. doi: 10.1016/j.bbmt.2011.06.006. Epub 2011 Jun 25.'}, {'pmid': '3321587', 'type': 'BACKGROUND', 'citation': 'Jones RJ, Lee KS, Beschorner WE, Vogel VG, Grochow LB, Braine HG, Vogelsang GB, Sensenbrenner LL, Santos GW, Saral R. Venoocclusive disease of the liver following bone marrow transplantation. Transplantation. 1987 Dec;44(6):778-83. doi: 10.1097/00007890-198712000-00011.'}, {'pmid': '6363247', 'type': 'BACKGROUND', 'citation': 'McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED. Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology. 1984 Jan-Feb;4(1):116-22. doi: 10.1002/hep.1840040121.'}, {'pmid': '27183098', 'type': 'BACKGROUND', 'citation': 'Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Duarte RF, Carreras E. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant. 2016 Jul;51(7):906-12. doi: 10.1038/bmt.2016.130. Epub 2016 May 16.'}, {'pmid': '28759025', 'type': 'BACKGROUND', 'citation': 'Corbacioglu S, Carreras E, Ansari M, Balduzzi A, Cesaro S, Dalle JH, Dignan F, Gibson B, Guengoer T, Gruhn B, Lankester A, Locatelli F, Pagliuca A, Peters C, Richardson PG, Schulz AS, Sedlacek P, Stein J, Sykora KW, Toporski J, Trigoso E, Vetteranta K, Wachowiak J, Wallhult E, Wynn R, Yaniv I, Yesilipek A, Mohty M, Bader P. Diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in pediatric patients: a new classification from the European society for blood and marrow transplantation. Bone Marrow Transplant. 2018 Feb;53(2):138-145. doi: 10.1038/bmt.2017.161. Epub 2017 Jul 31.'}, {'pmid': '24102514', 'type': 'BACKGROUND', 'citation': 'Dignan FL, Wynn RF, Hadzic N, Karani J, Quaglia A, Pagliuca A, Veys P, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. BCSH/BSBMT guideline: diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantation. Br J Haematol. 2013 Nov;163(4):444-57. doi: 10.1111/bjh.12558. Epub 2013 Sep 17.'}, {'pmid': '15994282', 'type': 'BACKGROUND', 'citation': 'Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.'}, {'pmid': '28444784', 'type': 'BACKGROUND', 'citation': 'Richardson PG, Smith AR, Triplett BM, Kernan NA, Grupp SA, Antin JH, Lehmann L, Miloslavsky M, Hume R, Hannah AL, Nejadnik B, Soiffer RJ. Earlier defibrotide initiation post-diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome improves Day +100 survival following haematopoietic stem cell transplantation. Br J Haematol. 2017 Jul;178(1):112-118. doi: 10.1111/bjh.14727. Epub 2017 Apr 26.'}, {'pmid': '23333447', 'type': 'BACKGROUND', 'citation': 'Berzigotti A, Castera L. Update on ultrasound imaging of liver fibrosis. J Hepatol. 2013 Jul;59(1):180-2. doi: 10.1016/j.jhep.2012.12.028. Epub 2013 Jan 15. No abstract available.'}, {'pmid': '12134100', 'type': 'BACKGROUND', 'citation': 'Lassau N, Auperin A, Leclere J, Bennaceur A, Valteau-Couanet D, Hartmann O. Prognostic value of doppler-ultrasonography in hepatic veno-occlusive disease. Transplantation. 2002 Jul 15;74(1):60-6. doi: 10.1097/00007890-200207150-00011.'}, {'pmid': '9240551', 'type': 'BACKGROUND', 'citation': 'Lassau N, Leclere J, Auperin A, Bourhis JH, Hartmann O, Valteau-Couanet D, Benhamou E, Bosq J, Ibrahim A, Girinski T, Pico JL, Roche A. Hepatic veno-occlusive disease after myeloablative treatment and bone marrow transplantation: value of gray-scale and Doppler US in 100 patients. Radiology. 1997 Aug;204(2):545-52. doi: 10.1148/radiology.204.2.9240551.'}, {'pmid': '24710567', 'type': 'BACKGROUND', 'citation': 'Karlas T, Weber J, Nehring C, Kronenberger R, Tenckhoff H, Mossner J, Niederwieser D, Troltzsch M, Lange T, Keim V. Value of liver elastography and abdominal ultrasound for detection of complications of allogeneic hemopoietic SCT. Bone Marrow Transplant. 2014 Jun;49(6):806-11. doi: 10.1038/bmt.2014.61. Epub 2014 Apr 7.'}, {'pmid': '22705804', 'type': 'BACKGROUND', 'citation': 'Auberger J, Graziadei I, Clausen J, Vogel W, Nachbaur D. Non-invasive transient elastography for the prediction of liver toxicity following hematopoietic SCT. Bone Marrow Transplant. 2013 Jan;48(1):159-60. doi: 10.1038/bmt.2012.113. Epub 2012 Jun 18. No abstract available.'}, {'pmid': '14698338', 'type': 'BACKGROUND', 'citation': 'Sandrin L, Fourquet B, Hasquenoph JM, Yon S, Fournier C, Mal F, Christidis C, Ziol M, Poulet B, Kazemi F, Beaugrand M, Palau R. Transient elastography: a new noninvasive method for assessment of hepatic fibrosis. Ultrasound Med Biol. 2003 Dec;29(12):1705-13. doi: 10.1016/j.ultrasmedbio.2003.07.001.'}, {'pmid': '22039033', 'type': 'BACKGROUND', 'citation': 'Fontanilla T, Hernando CG, Claros JC, Bautista G, Minaya J, Del Carmen Vega M, Piazza A, Mendez S, Rodriguez C, Aranguena RP. Acoustic radiation force impulse elastography and contrast-enhanced sonography of sinusoidal obstructive syndrome (Veno-occlusive Disease): preliminary results. J Ultrasound Med. 2011 Nov;30(11):1593-8. doi: 10.7863/jum.2011.30.11.1593.'}, {'pmid': '18397389', 'type': 'BACKGROUND', 'citation': 'Bureau C, Metivier S, Peron JM, Selves J, Robic MA, Gourraud PA, Rouquet O, Dupuis E, Alric L, Vinel JP. Transient elastography accurately predicts presence of significant portal hypertension in patients with chronic liver disease. Aliment Pharmacol Ther. 2008 Jun;27(12):1261-8. doi: 10.1111/j.1365-2036.2008.03701.x. Epub 2008 Apr 4.'}, {'pmid': '23859217', 'type': 'BACKGROUND', 'citation': 'Bota S, Herkner H, Sporea I, Salzl P, Sirli R, Neghina AM, Peck-Radosavljevic M. Meta-analysis: ARFI elastography versus transient elastography for the evaluation of liver fibrosis. Liver Int. 2013 Sep;33(8):1138-47. doi: 10.1111/liv.12240. Epub 2013 Jul 16.'}, {'pmid': '18836992', 'type': 'BACKGROUND', 'citation': 'Millonig G, Reimann FM, Friedrich S, Fonouni H, Mehrabi A, Buchler MW, Seitz HK, Mueller S. Extrahepatic cholestasis increases liver stiffness (FibroScan) irrespective of fibrosis. Hepatology. 2008 Nov;48(5):1718-23. doi: 10.1002/hep.22577.'}, {'pmid': '23558397', 'type': 'BACKGROUND', 'citation': "Bamber J, Cosgrove D, Dietrich CF, Fromageau J, Bojunga J, Calliada F, Cantisani V, Correas JM, D'Onofrio M, Drakonaki EE, Fink M, Friedrich-Rust M, Gilja OH, Havre RF, Jenssen C, Klauser AS, Ohlinger R, Saftoiu A, Schaefer F, Sporea I, Piscaglia F. EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 1: Basic principles and technology. Ultraschall Med. 2013 Apr;34(2):169-84. doi: 10.1055/s-0033-1335205. Epub 2013 Apr 4."}, {'pmid': '18353109', 'type': 'BACKGROUND', 'citation': 'Lucena MI, Garcia-Cortes M, Cueto R, Lopez-Duran J, Andrade RJ. Assessment of drug-induced liver injury in clinical practice. Fundam Clin Pharmacol. 2008 Apr;22(2):141-58. doi: 10.1111/j.1472-8206.2008.00566.x.'}, {'pmid': '24617687', 'type': 'BACKGROUND', 'citation': 'del Campo L, Leon NG, Palacios DC, Lagana C, Tagarro D. Abdominal complications following hematopoietic stem cell transplantation. Radiographics. 2014 Mar-Apr;34(2):396-412. doi: 10.1148/rg.342135046.'}, {'pmid': '25798682', 'type': 'BACKGROUND', 'citation': 'Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Duarte RF, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Pagluica T, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Carreras E. Sinusoidal obstruction syndrome/veno-occlusive disease: current situation and perspectives-a position statement from the European Society for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 2015 Jun;50(6):781-9. doi: 10.1038/bmt.2015.52. Epub 2015 Mar 23.'}, {'pmid': '27941774', 'type': 'BACKGROUND', 'citation': 'Colecchia A, Marasco G, Ravaioli F, Kleinschmidt K, Masetti R, Prete A, Pession A, Festi D. Usefulness of liver stiffness measurement in predicting hepatic veno-occlusive disease development in patients who undergo HSCT. Bone Marrow Transplant. 2017 Mar;52(3):494-497. doi: 10.1038/bmt.2016.320. Epub 2016 Dec 12. No abstract available.'}, {'pmid': '40253530', 'type': 'DERIVED', 'citation': 'Ravaioli F, Colecchia A, Peccatori J, Pagliara D, Grassi A, Barbato F, Masetti R, Sarina B, Sica S, Cesaro S, Nozzoli C, Assanto GM, Prezioso L, Santarone S, Saglio F, Vanni E, Olivieri A, Delia M, Benedetti E, Zallio F, Pane F, Skert C, Menconi M, Benedetti F, De Felice F, Colecchia L, Belotti T, Alemanni LV, Ursi M, Marasco G, Roberto M, Vestito A, Dajti E, Garcovich M, Bramanti S, Taurino D, Quagliarella F, Ciceri F, Prete A, Pession A, Festi D; ELASTOVOD Study Group; Bonifazi F. Diagnostic accuracy of liver stiffness measurement for the diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome after hematopoietic stem cell transplantation (HSCT), the ELASTOVOD STUDY: an investigator-initiated, prospective, multicentre diagnostic clinical trial. Bone Marrow Transplant. 2025 Jul;60(7):978-993. doi: 10.1038/s41409-025-02570-w. Epub 2025 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'ELASTOVOD is a prospective multicenter study, involving several centers of Onco-haematology in Italy. Investigators perform hepatic elastographic measurements (with Transient Elastography, ARFI or 2D-SWE) on patients undergoing HSCT, at baseline before transplantation (T0) and at T1/T2/T3 after HSCT (+9/10, +15/17, +22/24).\n\nSOS/VOD diagnosis was performed according to clinical criteria.', 'detailedDescription': 'Sinusoidal Obstruction Syndrome (SOS), also known as hepatic Veno-Occlusive Disease (VOD), is a life-threatening complication in patients undergoing Hematopoietic Stem Cells Transplantation (HSCT) for onco-haematological disease.\n\nIn the severe form, mortality rate can be high as 80%. Patients developing SOS/VOD present a higher survival rate when earlier SOS/VOD- specific therapy has initiated. In order to get better outcomes, it is necessary to improve early diagnosis of SOS/VOD, finding new non--invasive diagnostic instruments.\n\nThe aim of this prospective multicenter study is to assess in a large, mixed (adult and paediatric) population undergoing HSCT, the diagnostic role for SOS/VOS of Liver Stiffness Measurement (LSM), assessed by different elastographic methods.\n\nIn our study, Liver Stiffness Measurement (LSM) can be measured by Transient Elastography (TE) with Fibroscan, Acoustic Radiation Force Impulse (ARFI) or 2D-Share Wave Elastography (2D-SWE). Once chosen an elastometric method at baseline, the same must be used for all subsequent evaluations of the patient.\n\nIn patients undergoing HSCT, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, haematological and hepatological anamnesis, in order to assess comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; abdominal Color-Doppler Ultrasound and hepatic Elastography (with Transient Elastography, ARFI or 2D-SWE).\n\nAfter conditioning and HSCT, each patient is evaluated at T1 (+9/10), T2 (+15/17), T3 (+22/24) with: bedside Elastography, laboratory tests, clinical examination based on clinical criteria for SOS/VOD diagnosis (e.g. Baltimora criteria, modified Seattle criteria, new EBMT criteria).\n\nRUCAM-CIOMS Scale can be assess, in order to establish DILI (Drug Induced Liver Injury) diagnosis, as well.\n\nIn case of SOS/VOD suspicion, patient goes through an intense monitoring period: laboratory tests, clinical evaluation for SOS/VOD diagnosis, Color-Doppler US and Elastography are repeatedly performed in next days. This monitoring period stops if diagnosis of SOS/VOD or other diagnosis is reached.\n\nEach center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients\n* age between 3 and 70\n* patients suffering from an onco-hematological disease that have an indication for either allogenic or autologous hematopoietic stem cells transplantation\n* obtaining of informed consent\n\nExclusion Criteria:\n\n* pathological obesity (BMI \\>40)\n* pacemaker of implantable defibrillator\n* presence of ascites at baseline'}, 'identificationModule': {'nctId': 'NCT03426358', 'acronym': 'ELASTOVOD', 'briefTitle': 'Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Usefulness of Liver Stiffness Measurement in Predicting Hepatic Veno-Occlusive Disease Development in Patients Who Undergo HSCT: a Multicentric Prospective Study', 'orgStudyIdInfo': {'id': 'ELASTOVOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients undergoing HSCT', 'description': 'LSM assessed by Elastographic Techniques', 'interventionNames': ['Device: LSM assessed by Elastographic Techniques']}], 'interventions': [{'name': 'LSM assessed by Elastographic Techniques', 'type': 'DEVICE', 'description': 'Performing Transient Elastography, ARFI or 2D-SWE on patients at baseline (within 1 month before HSCT) and after HSCT on days +9/10, +15/17, +22/24', 'armGroupLabels': ['Patients undergoing HSCT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'San Giovanni Rotondo', 'state': 'Foggia', 'country': 'Italy', 'facility': 'Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Tricase', 'state': 'Lecce', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "Card. G. Panico"', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Policlinico Umberto I - Università la Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Alessandria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera-Nazionale SS. 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Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Integrata di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Integrata di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Vicenza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Vicenza', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'overallOfficials': [{'name': 'Antonio Colecchia, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera-Universitaria Integrata di Verona'}, {'name': 'Francesca Bonifazi, Ph.D. M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna"}, {'name': 'Andrea Passion, Prof. M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (PI)', 'investigatorFullName': 'Davide Festi', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}