Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT06642168
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-01-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of the Cause of Sports-Related Cardiorespiratory Arrest in a Young, Healthy Population', 'timeFrame': 'Through study completion, approximately 39 months', 'description': 'The results for each identified cause of sports-related cardiorespiratory arrest will be presented as the total number of cases (n) and the percentage of the total cases. A 95% confidence interval will also be provided.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the Contribution of Medical Autopsy in Identifying the Etiology of Sports-Related SCA', 'timeFrame': '3 to 6 months after the event', 'description': 'Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.'}, {'measure': 'Evaluation of the Contribution of Classical Genetic Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest', 'timeFrame': '3 to 6 months after the event', 'description': 'The results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.'}, {'measure': 'Evaluation of the Contribution of Whole Exome Sequencing in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest', 'timeFrame': '24 to 30 months after the event', 'description': 'Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.'}, {'measure': 'Evaluation of the Contribution of Toxicological Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest', 'timeFrame': '3 to 6 months after the event', 'description': 'Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.'}, {'measure': 'Evaluation of the Familial Transmission of Hereditary Cardiovascular Pathologies Detected', 'timeFrame': '3 to 12 months after the event.', 'description': 'Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sport related sudden cardiac arrest', 'Sport related sudden cardiac death', 'Young athlete', 'Etiological Diagnosis', 'Autopsy', 'Genetic', 'Toxicology', 'Hereditary Cardiac disease', 'Prevention'], 'conditions': ['Sudden Cardiac Arrest', 'Sudden Cardiac Death']}, 'descriptionModule': {'briefSummary': "The increased risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) related to vigorous physical activity is well-documented. Currently, for young victims (under 35 years) of SCA/SCD, no etiology is found in 40 to 50% of cases after a standard medical assessment, leading to two important consequences. For the victim's family, it is difficult to understand and accept this tragic event, and the risk of it occurring in another family member is a source of concern. Medically, the absence of a known cause limits the ability to effectively prevent such events.\n\nThe RESOUDRE study will be a national, prospective, observational registry of young victims (12-35 years) of sports-related SCA/SCD. All cases will undergo the recommended etiological assessment, including autopsy for SCA cases, along with whole exome genetic analysis and toxicological testing. In the event a genetic pathology is identified, a genetic evaluation will be offered to other family members, and appropriate medical care will be provided if necessary. The results of this study could significantly reduce the number of unexplained sport-related SCA/SCD cases and aid in preventing these incidents among affected families.", 'detailedDescription': 'Background:\n\nThe beneficial effects of moderate physical activity on health are well-established. However, it is also well-proven that intense sports participation increases the risk of cardiovascular events by 2.4 to 4.5 times before the age of 35 in individuals with known or unknown heart conditions. Sudden cardiac arrest (SCA), sometimes leading to sudden cardiac death (SCD), is the most dramatic event linked to sports.\n\nBefore the age of 35, sports-related SCA/SCD is rare, occurring in 0.7 to 2.7 per 100,000 athletes, which amounts to approximately 80 cases per year according to two French prospective studies. Despite its rarity, these events are often traumatic and highly publicized, presenting a significant public health and safety concern. Non-traumatic sports-related SCA/SCD is primarily of cardiovascular origin, irrespective of the level of sports participation. In most cases, SCA results from ventricular arrhythmia caused by known or undiagnosed arrhythmogenic cardiovascular disease, which varies by the victim\'s age. After the age of 35, atheromatous coronary artery disease accounts for 80-85% of cases. However, before the age of 35, a wider range of etiologies are observed. Arrhythmogenic genetic heart diseases-structural (e.g., arrhythmogenic right ventricular cardiomyopathy and hypertrophic cardiomyopathy) or non-structural (e.g., channelopathies)-are the most frequent causes. Congenital abnormalities, particularly anomalous connection of coronary artery, represent the second most common cause. Acquired heart diseases, such as fibrous scars (mainly post-myocarditis) and atheromatous coronary lesions, are less frequently involved. In this younger population, classical autopsy often fails to determine the cause in more than 40% of cases, leading to the term "sudden arrhythmic syndrome".\n\nFew prospective studies have combined classical autopsy with systematic genetic analysis to identify the cause of SCA/SCD in the general young population, with no specific link to sports. One Australian study demonstrated the value of genetic testing, identifying a "clinically relevant" cardiac genetic variant for sudden death in 27% of cases. Moreover, the same pathology was identified in 13% of relatives of the victims who underwent clinical and genetic screening. Another small Swedish study (n=15), focusing specifically on channelopathies in cases of negative autopsies, revealed the disease in 40% of victims\' families through genetic analysis.\n\nAdditionally, the role of acute or chronic toxic substance intake has been suggested, albeit without formal proof, as a factor promoting sports-related SCA/SCD. Toxicological screening is thus recommended as part of the etiological assessment. Including toxicological analysis alongside other etiological evaluations could help clarify the impact of illicit substances on sports-related SCA/SCD.\n\nJustifications for the Study:\n\nNo prospective study has systematically combined the recommended hospital assessment in cases of successful resuscitation or the recommended medical autopsy in the event of death with global genetic and toxicological analyses in victims of sports-related SCA/SCD.\n\nThis combined approach is justified for several reasons. First, it would enhance our understanding of the etiologies of these events. Notably, so-called idiopathic left ventricular hypertrophy is found in more than 10% of sports-related SCD cases following classical autopsies. Further genetic exploration could help determine whether these anatomical forms are pathological. Additionally, many arrhythmic cardiac diseases are associated with an elevated risk of sports-related SCA/SCD. While arrhythmogenic right ventricular cardiomyopathy is well-documented, other forms of disease are characterized by areas of fibrosis or fatty infiltration in the myocardium, often due to genetic mutations affecting intercellular desmosomes. Comprehensive genetic testing, including whole exome sequencing, could clarify the contribution of various arrhythmogenic heart diseases to unexplained sports-related SCA/SCD.\n\nImproving this knowledge will benefit ongoing discussions about enhancing the content and effectiveness of pre-participation screening for athletes. Moreover, identifying the cause of SCA/SCD is critical for the victims and their families. Understanding the cause may help families come to terms with the event and assist in preventing recurrence for successfully resuscitated individuals. Furthermore, since most hereditary heart diseases follow an autosomal dominant inheritance pattern, each first-degree relative has a 50% chance of carrying the same genetic mutation. Predictive testing, clinical assessment, and, if necessary, preventive treatment can be offered to these family members to reduce the risk of arrhythmic events.\n\nStatistical Analysis:\n\nData analyses will be performed using specialized software, with a significance threshold set at 5%. Hypotheses will be formulated bilaterally.\n\nA descriptive analysis of the collected population data will be conducted. Qualitative variables will be presented as numbers and percentages, while quantitative variables will be described using the mean, standard deviation, median, interquartile range, minimum, and maximum values.\n\nFor the primary analysis of the main outcome, the cause of sports-related SCA/SCD will be described in terms of numbers and percentages, along with the corresponding 95% confidence intervals.\n\nFor the secondary analyses, the judgment criteria, both overall and by vital status (survived or deceased), will be described in numbers and percentages, with 95% confidence intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include French victims of sports-related SCA/SCD between the ages of 12 and 35, as well as their first-degree relatives over 12 years of age, when applicable.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Victims of SCA:\n\n * Aged between 12 and 35 years\n * No known cardiovascular pathology\n * Experienced a sudden and non-traumatic SCA during or within one hour of participating in sports activities (leisure, training, or competition)\n * For resuscitated victims (SCA group): A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, organs, or authorities responsible for assisting or representing them if they are unable to express their wishes).\n * For non-resuscitated victims (SCD group): A person who has not formally objected to the reuse of their medical data during their lifetime.\n* First-Degree Relatives:\n\n * A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, bodies, or authorities responsible for assisting or representing them if they are unable to express their wishes).\n\nNon-Inclusion Criteria:\n\n* For resuscitated SCA cases, individuals weighing less than 20 kg\n* Victims or legal representatives who are subject to legal protection or deprived of their liberty'}, 'identificationModule': {'nctId': 'NCT06642168', 'acronym': 'RESOUDRE', 'briefTitle': 'Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Registre Prospectif Français Des Morts Subites Chez Des Sportifs Jeunes', 'orgStudyIdInfo': {'id': '35RC19_8911_RESOUDRE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Victims of sport-related sudden cardiac arrest (SCA) : resuscitated SCA and non-resuscitated SCA', 'description': 'Following a sport-related sudden cardiac arrest (SCA), resuscitation attempts are frequently made due to the high likelihood of witnesses at the scene. These resuscitation efforts are successful in more than 40% of cases. The study population will therefore be divided into two groups: a group of resuscitated SCA victims (SCA group) and a group of non-resuscitated or unsuccessfully resuscitated victims (SCD group).\n\nThe RESOUDRE study is an observational study focusing on individuals who have experienced SCA. Depending on the outcome-whether the individual survives or not-the etiological assessment will differ. While the study design refers to two distinct groups for clarity, they represent a single population, and no statistical comparison between the two groups will be made.', 'interventionNames': ['Genetic: Whole exome sequencing to detect myocardial genetic mutations (SCA group only)']}], 'interventions': [{'name': 'Whole exome sequencing to detect myocardial genetic mutations (SCA group only)', 'type': 'GENETIC', 'description': 'Whole exome sequencing to detect myocardial genetic mutations', 'armGroupLabels': ['Victims of sport-related sudden cardiac arrest (SCA) : resuscitated SCA and non-resuscitated SCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75877', 'city': 'Paris', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice EXTRAMIANA', 'role': 'CONTACT', 'email': 'fabrice.extramiana@aphp.fr'}, {'name': 'Fabrice EXTRAMIANA', 'role': 'CONTACT'}], 'facility': 'APHP Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eloi MARIJON', 'role': 'CONTACT', 'email': 'eloi.marijon@aphp.fr'}, {'name': 'Eloi MARIJON', 'role': 'CONTACT'}], 'facility': 'APHP Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric SCHNELL', 'role': 'CONTACT', 'email': 'frederic.schnell@chu-rennes.fr'}, {'name': 'Frédéric SCHNELL', 'role': 'CONTACT'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '25030', 'city': 'Besançon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François SCHIELE', 'role': 'CONTACT', 'email': 'francois.schiele@univ-fcomte.fr'}, {'name': 'François SCHIELE', 'role': 'CONTACT'}], 'facility': 'CHRU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33600', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric SACHER', 'role': 'CONTACT', 'email': 'frederic.sacher@chu-bordeaux.fr'}, {'name': 'Frédéric SACHER', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques MANSOURATI', 'role': 'CONTACT', 'email': 'jacques.mansourati@chu-brest.fr'}, {'name': 'Jacques MANSOURATI', 'role': 'CONTACT'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Paul MILLIEZ', 'role': 'CONTACT', 'email': 'milliez-p@chu-caen.fr'}, {'name': 'Paul MILLIEZ', 'role': 'CONTACT'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain ESCHALIER', 'role': 'CONTACT', 'email': 'reschalier@chu-clermontferrand.fr'}, {'name': 'Romain ESCHALIER', 'role': 'CONTACT'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas LELLOUCHE', 'role': 'CONTACT', 'email': 'nicolas.lellouche@aphp.fr'}, {'name': 'Nicolas LELLOUCHE', 'role': 'CONTACT'}], 'facility': 'APHP Hôpital Henri-Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel LAURENT', 'role': 'CONTACT', 'email': 'gabriel.laurent@chu-dijon.fr'}, {'name': 'Gabriel LAURENT', 'role': 'CONTACT'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal DEFAYE', 'role': 'CONTACT', 'email': 'PDefaye@chu-grenoble.fr'}, {'name': 'Pascal DEFAYE', 'role': 'CONTACT'}], 'facility': 'CHU de Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier KLUG', 'role': 'CONTACT', 'email': 'Didier.KLUG@chu-lille.fr'}, {'name': 'Didier KLUG', 'role': 'CONTACT'}], 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69229', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe CHEVALIER', 'role': 'CONTACT', 'email': 'philippe.chevalier@chu-lyon.fr'}, {'name': 'Philippe CHEVALIER', 'role': 'CONTACT'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13364', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Claude DEHARO', 'role': 'CONTACT', 'email': 'JeanClaude.DEHARO@ap-hm.fr'}, {'name': 'Jean-Claude DEHARO', 'role': 'CONTACT'}], 'facility': 'APHM Hôpitaux universitaires de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc PASQUIE', 'role': 'CONTACT', 'email': 'jl-pasquie@chu-montpellier.fr'}, {'name': 'Jean-Luc PASQUIE', 'role': 'CONTACT'}], 'facility': 'CHRU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne ALIOT', 'role': 'CONTACT', 'email': 'E.ALIOT@chru-nancy.fr'}, {'name': 'Etienne ALIOT', 'role': 'CONTACT'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent PROBST', 'role': 'CONTACT', 'email': 'vincent.probst@chu-nantes.fr'}, {'name': 'Vincent PROBST', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06003', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier SCARLATTI', 'role': 'CONTACT', 'email': 'scarlatti.d@chu-nice.fr'}, {'name': 'Didier SCARLATTI', 'role': 'CONTACT'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75651', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Estelle GANDJBAKHCH', 'role': 'CONTACT', 'email': 'estelle.gandjbakhch@aphp.fr'}, {'name': 'Estelle GANDJBAKHCH', 'role': 'CONTACT'}], 'facility': 'APHP Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rodrigue GARCIA', 'role': 'CONTACT', 'email': 'rodrigue.garcia@chu-poitiers.fr'}, {'name': 'Rodrigue GARCIA', 'role': 'CONTACT'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien METZ', 'role': 'CONTACT', 'email': 'dmetz@chu-reims.fr'}, {'name': 'Damien METZ', 'role': 'CONTACT'}], 'facility': 'CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric ANSELME', 'role': 'CONTACT', 'email': 'Frederic.Anselme@chu-rouen.fr'}, {'name': 'Frédéric ANSELME', 'role': 'CONTACT'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42100', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine DA COSTA', 'role': 'CONTACT', 'email': 'antoine.dacosta@univ-st-etienne.fr'}, {'name': 'Antoine DA COSTA', 'role': 'CONTACT'}], 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence JESEL-MOREL', 'role': 'CONTACT', 'email': 'Laurence.JESEL-MOREL@chru-strasbourg.fr'}, {'name': 'Laurence JESEL-MOREL', 'role': 'CONTACT'}], 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe MAURY', 'role': 'CONTACT', 'email': 'maury.p@chu-toulouse.fr'}, {'name': 'Philippe MAURY', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice IVANES', 'role': 'CONTACT', 'email': 'F.IVANES@chu-tours.fr'}, {'name': 'Fabrice IVANES', 'role': 'CONTACT'}], 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Frédéric SCHNELL', 'role': 'CONTACT', 'email': 'frederic.schnell@chu-rennes.fr', 'phone': '0299284133'}, {'name': 'Stéphanie Jolly', 'role': 'CONTACT', 'email': 'stephanie.jolly@chu-rennes.fr', 'phone': '0299282555'}], 'overallOfficials': [{'name': 'Frédéric SCHNELL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}