Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-03 @ 4:20 AM
Study NCT ID:
NCT06480994
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Frozen plasma aliquots collected on citrated tubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1836}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of the new clinical decision support with fresh plasma', 'timeFrame': '37 months', 'description': 'Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.'}, {'measure': 'Threshold of the new clinical decision support with fresh plasma', 'timeFrame': '37 months', 'description': 'Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.'}, {'measure': 'PE / DVT sensitivity of the clinical decision support', 'timeFrame': '48 months', 'description': 'Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.'}, {'measure': 'PE / DVT specificity of the clinical decision support', 'timeFrame': '48 months', 'description': 'Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.'}, {'measure': 'PE / DVT likelihood ratio of the clinical decision support', 'timeFrame': '48 months', 'description': 'Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.'}, {'measure': 'PE / DVT exclusion percentage of the clinical decision support', 'timeFrame': '48 months', 'description': 'Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.'}, {'measure': 'PE / DVT negative predictive value of the clinical decision support', 'timeFrame': '48 months', 'description': 'Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboembolism', 'Pulmonary Embolism', 'Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Contant G., Mirshahi S.S., Depasse F., Soria J. A new D-dimer concept for more specific detection of venous thromboembolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1385, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017'}, {'type': 'BACKGROUND', 'citation': 'Planquette B, Jumel S, Pastre J, Pereira H, Marey J, Roche A, Chatellier G, Sanchez O and Meyer G. SOFIE: Soluble Fibrin for Diagnosing Pulmonary Embolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1393, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017.'}, {'type': 'BACKGROUND', 'citation': 'Heit JA, Cohen AT, Anderson FA. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the US. Blood 2005;106(11):910'}, {'pmid': '17938798', 'type': 'BACKGROUND', 'citation': 'Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.'}, {'pmid': '25302663', 'type': 'BACKGROUND', 'citation': 'ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90. doi: 10.1111/jth.12698.'}, {'pmid': '12814980', 'type': 'BACKGROUND', 'citation': 'Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I9-16. doi: 10.1161/01.CIR.0000078469.07362.E6.'}, {'pmid': '17635707', 'type': 'BACKGROUND', 'citation': 'Wells PS. Integrated strategies for the diagnosis of venous thromboembolism. J Thromb Haemost. 2007 Jul;5 Suppl 1:41-50. doi: 10.1111/j.1538-7836.2007.02493.x.'}, {'pmid': '9428249', 'type': 'BACKGROUND', 'citation': 'Wells PS, Anderson DR, Bormanis J, Guy F, Mitchell M, Gray L, Clement C, Robinson KS, Lewandowski B. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet. 1997 Dec 20-27;350(9094):1795-8. doi: 10.1016/S0140-6736(97)08140-3.'}, {'pmid': '16461960', 'type': 'BACKGROUND', 'citation': 'Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Bounameaux H, Perrier A. Prediction of pulmonary embolism in the emergency department: the revised Geneva score. Ann Intern Med. 2006 Feb 7;144(3):165-71. doi: 10.7326/0003-4819-144-3-200602070-00004.'}, {'pmid': '28594049', 'type': 'BACKGROUND', 'citation': 'Schulman S, Ageno W, Konstantinides SV. Venous thromboembolism: Past, present and future. Thromb Haemost. 2017 Jun 28;117(7):1219-1229. doi: 10.1160/TH16-10-0823. Epub 2017 Jun 8.'}, {'pmid': '17155963', 'type': 'BACKGROUND', 'citation': 'Di Nisio M, Squizzato A, Rutjes AW, Buller HR, Zwinderman AH, Bossuyt PM. Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review. J Thromb Haemost. 2007 Feb;5(2):296-304. doi: 10.1111/j.1538-7836.2007.02328.x. Epub 2006 Nov 28.'}, {'pmid': '17635709', 'type': 'BACKGROUND', 'citation': 'Righini M. Is it worth diagnosing and treating distal deep vein thrombosis? No. J Thromb Haemost. 2007 Jul;5 Suppl 1:55-9. doi: 10.1111/j.1538-7836.2007.02468.x.'}, {'pmid': '24762450', 'type': 'BACKGROUND', 'citation': 'Pawelec G, Goldeck D, Derhovanessian E. Inflammation, ageing and chronic disease. Curr Opin Immunol. 2014 Aug;29:23-8. doi: 10.1016/j.coi.2014.03.007. Epub 2014 Apr 22.'}, {'pmid': '20305364', 'type': 'BACKGROUND', 'citation': 'Tita-Nwa F, Bos A, Adjei A, Ershler WB, Longo DL, Ferrucci L. Correlates of D-dimer in older persons. Aging Clin Exp Res. 2010 Feb;22(1):20-3. doi: 10.1007/BF03324810.'}, {'pmid': '17543005', 'type': 'BACKGROUND', 'citation': 'Harper PL, Theakston E, Ahmed J, Ockelford P. D-dimer concentration increases with age reducing the clinical value of the D-dimer assay in the elderly. Intern Med J. 2007 Sep;37(9):607-13. doi: 10.1111/j.1445-5994.2007.01388.x. Epub 2007 Jun 2.'}, {'pmid': '25503584', 'type': 'BACKGROUND', 'citation': 'Righini M, Le Gal G, Bounameaux H. Venous thromboembolism diagnosis: unresolved issues. Thromb Haemost. 2015 Jun;113(6):1184-92. doi: 10.1160/TH14-06-0530. Epub 2014 Dec 11.'}, {'pmid': '26585807', 'type': 'BACKGROUND', 'citation': 'Huisman MV, Klok FA. Current challenges in diagnostic imaging of venous thromboembolism. Blood. 2015 Nov 19;126(21):2376-82. doi: 10.1182/blood-2015-05-640979.'}, {'pmid': '15935031', 'type': 'BACKGROUND', 'citation': 'Righini M, Le Gal G, Perrier A, Bounameaux H. The challenge of diagnosing pulmonary embolism in elderly patients: influence of age on commonly used diagnostic tests and strategies. J Am Geriatr Soc. 2005 Jun;53(6):1039-45. doi: 10.1111/j.1532-5415.2005.53309.x.'}, {'pmid': '16403929', 'type': 'BACKGROUND', 'citation': 'van Belle A, Buller HR, Huisman MV, Huisman PM, Kaasjager K, Kamphuisen PW, Kramer MH, Kruip MJ, Kwakkel-van Erp JM, Leebeek FW, Nijkeuter M, Prins MH, Sohne M, Tick LW; Christopher Study Investigators. Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. JAMA. 2006 Jan 11;295(2):172-9. doi: 10.1001/jama.295.2.172.'}, {'pmid': '28085911', 'type': 'BACKGROUND', 'citation': 'Pernod G, Caterino J, Maignan M, Tissier C, Kassis J, Lazarchick J; DIET study group. D-Dimer Use and Pulmonary Embolism Diagnosis in Emergency Units: Why Is There Such a Difference in Pulmonary Embolism Prevalence between the United States of America and Countries Outside USA? PLoS One. 2017 Jan 13;12(1):e0169268. doi: 10.1371/journal.pone.0169268. eCollection 2017.'}, {'pmid': '24643601', 'type': 'BACKGROUND', 'citation': 'Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135.'}, {'pmid': '28549662', 'type': 'BACKGROUND', 'citation': 'van der Hulle T, Cheung WY, Kooij S, Beenen LFM, van Bemmel T, van Es J, Faber LM, Hazelaar GM, Heringhaus C, Hofstee H, Hovens MMC, Kaasjager KAH, van Klink RCJ, Kruip MJHA, Loeffen RF, Mairuhu ATA, Middeldorp S, Nijkeuter M, van der Pol LM, Schol-Gelok S, Ten Wolde M, Klok FA, Huisman MV; YEARS study group. Simplified diagnostic management of suspected pulmonary embolism (the YEARS study): a prospective, multicentre, cohort study. Lancet. 2017 Jul 15;390(10091):289-297. doi: 10.1016/S0140-6736(17)30885-1. Epub 2017 May 23.'}, {'pmid': '29450523', 'type': 'BACKGROUND', 'citation': 'Freund Y, Cachanado M, Aubry A, Orsini C, Raynal PA, Feral-Pierssens AL, Charpentier S, Dumas F, Baarir N, Truchot J, Desmettre T, Tazarourte K, Beaune S, Leleu A, Khellaf M, Wargon M, Bloom B, Rousseau A, Simon T, Riou B; PROPER Investigator Group. Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):559-566. doi: 10.1001/jama.2017.21904.'}, {'pmid': '29150390', 'type': 'BACKGROUND', 'citation': 'Penaloza A, Soulie C, Moumneh T, Delmez Q, Ghuysen A, El Kouri D, Brice C, Marjanovic NS, Bouget J, Moustafa F, Trinh-Duc A, Le Gall C, Imsaad L, Chretien JM, Gable B, Girard P, Sanchez O, Schmidt J, Le Gal G, Meyer G, Delvau N, Roy PM. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study. Lancet Haematol. 2017 Dec;4(12):e615-e621. doi: 10.1016/S2352-3026(17)30210-7. Epub 2017 Nov 14.'}, {'pmid': '17208341', 'type': 'BACKGROUND', 'citation': 'Wolberg AS. Thrombin generation and fibrin clot structure. Blood Rev. 2007 May;21(3):131-42. doi: 10.1016/j.blre.2006.11.001. Epub 2007 Jan 8.'}, {'pmid': '28740853', 'type': 'BACKGROUND', 'citation': 'Undas A. Prothrombotic Fibrin Clot Phenotype in Patients with Deep Vein Thrombosis and Pulmonary Embolism: A New Risk Factor for Recurrence. Biomed Res Int. 2017;2017:8196256. doi: 10.1155/2017/8196256. Epub 2017 Jun 27.'}, {'pmid': '29225327', 'type': 'BACKGROUND', 'citation': 'Zabczyk M, Undas A. Plasma fibrin clot structure and thromboembolism: clinical implications. Pol Arch Intern Med. 2017 Dec 22;127(12):873-881. doi: 10.20452/pamw.4165. Epub 2017 Dec 11.'}, {'pmid': '27071050', 'type': 'BACKGROUND', 'citation': 'Undas A. How to Assess Fibrinogen Levels and Fibrin Clot Properties in Clinical Practice? Semin Thromb Hemost. 2016 Jun;42(4):381-8. doi: 10.1055/s-0036-1579636. Epub 2016 Apr 12.'}, {'pmid': '18628784', 'type': 'BACKGROUND', 'citation': 'Schafer M, Werner S. Cancer as an overhealing wound: an old hypothesis revisited. Nat Rev Mol Cell Biol. 2008 Aug;9(8):628-38. doi: 10.1038/nrm2455. Epub 2008 Jul 16.'}, {'pmid': '32338827', 'type': 'BACKGROUND', 'citation': 'Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Mahé I, Chidiac J, Djennaoui S, Javaud N, Planquette B, Peynaud-Debayle E, Sofiane Baccar L, Dumont B, Meyer G, Contant G, Depasse F, Siguret V, Helfer H. Evaluation of the Fibrin Assay for Venous Thromboembolism Exclusion in Cancer Patients: Subanalysis of a Prospective Assessment (FSET STUDY). Blood 134(Supplement_1):3663-3663, November 2019'}]}, 'descriptionModule': {'briefSummary': 'The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. The main question it aims to answer is :\n\nAre the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off? Participants will be diagnosed and treated in accordance with routine standard of care.', 'detailedDescription': 'Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma, in PE and in DVT, in comparison with that on frozen plasma, and in comparison with the current diagnostic strategy, on the entire population and on the following different subpopulations:\n\n* Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age)\n* Patients with high clinical probability, compared to the reference diagnosis (imaging)\n* Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events\n* Patients with known and active cancer\n* Patients with COVID-19. The assays will be conducted on a fresh and frozen plasma aliquots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age)\n* Patients with high clinical probability, compared to the reference diagnosis (imaging)\n* Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events\n* Patients with known and active cancer\n* Patients with COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PE and/or DVT suspicion\n* No opposition after informing the patient for his participation in research and processing of their data for this purpose,\n* Benefiting from the social security system\n\nExclusion Criteria:\n\n* Preventive or curative anticoagulant treatment, or fibrinolytic treatment,\n* Legal protection (e.g. guardianship or curatorship),\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT06480994', 'acronym': 'EXTEND', 'briefTitle': 'Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diagnostica Stago R&D'}, 'officialTitle': 'Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion', 'orgStudyIdInfo': {'id': 'EXTEND 2021-A03135-36'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Routine Assays on fresh plasma', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine coagulation tests using STA-R Max analyzer :\n\nProthrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity'}, {'name': 'New Clinical Decision Support on fresh plasma', 'type': 'DIAGNOSTIC_TEST', 'description': 'D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.'}, {'name': 'New Clinical Decision Support on frozen plasma', 'type': 'DIAGNOSTIC_TEST', 'description': 'D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79021', 'city': 'Niort', 'state': 'Sartres', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane Chuillet-Moreau', 'role': 'CONTACT', 'email': 'Diane.CHUILLET-MOREAU@ch-niort.fr', 'phone': '+33 (0) 549782049'}, {'name': 'Angélique Hubert', 'role': 'CONTACT', 'email': 'Angelique.HUBERT@ch-niort.fr', 'phone': '+33549782428'}, {'name': 'Mathieu Violeau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'zip': '72037', 'city': 'Le Mans', 'state': 'Sartre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Françoise Rosalie', 'role': 'CONTACT', 'email': 'frosalie@ch-lemans.fr', 'phone': '+33 (0) 243479970'}, {'name': 'Cyrielle Houalard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Johann Rose, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cindy Tissier, PhD', 'role': 'CONTACT', 'email': 'cindy.tissier@chu-dijon.fr', 'phone': '+33380295112'}, {'name': 'Cindy Tissier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emmanuel De Maistre, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Prudence Mabiala Makele, PhD', 'role': 'CONTACT', 'email': 'pmabialamakele@chu-grenoble.fr', 'phone': '+33476766784'}, {'name': 'Damien Viglino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raphael Marlu, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'AURELIE LAMIELLE', 'role': 'CONTACT', 'email': 'aurelie.lamielle@stago.com', 'phone': '0141471500'}, {'name': 'OLIVIER MATHIEU', 'role': 'CONTACT', 'email': 'olivier.mathieu@stago.com', 'phone': '0141471500'}], 'overallOfficials': [{'name': 'VINCENT VIOLEAU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier de Niort'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diagnostica Stago R&D', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre Hospitalier de Niort', 'class': 'OTHER'}, {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}