Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-28 @ 6:34 PM
Study NCT ID:
NCT06304233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2023-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D059552', 'term': 'Caves'}, {'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum, whole blood, peripheral blood mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2038-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire', 'timeFrame': 'Baseline', 'description': 'The AUDIT-C is a validated 3-item questionnaire for identification of alcohol misuse. Each item has 5 possible responses, each scored from 0 to 4 points. Possible scores range from 0 to 12. The score cut-off for alcohol misuse is 4 points in men and 3 points in women'}, {'measure': 'Average length of inpatient stay for schizophrenia related admissions', 'timeFrame': 'Baseline', 'description': 'The average length of inpatient stays will be reported as number of days and derived from the total number of days spent admitted over the total number of admissions.'}, {'measure': 'Need of Care based on number of total hospital admission for schizophrenia', 'timeFrame': 'Baseline', 'description': 'Number of hospital admissions'}, {'measure': 'Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity', 'timeFrame': 'Baseline', 'description': 'CGI for severity is a validated scale used to assess psychiatric illness severity by a clinician. Possible scores range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients)'}, {'measure': 'Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Baseline', 'description': 'PANSS/SCI-PANSS are validated clinician administered scale used to measure symptom severity in schizophrenia and consists of 30 items divided into 3 subscales: Positive Scale, Negative Scale and the General Pathology Scale. Each subscale can be scored from 1 (absent) to 7 (extreme). Possible scores for the Positive and Negative scales range from 7 - 49, and for the General Psychopathology Scale range from 16 - 112. The further developed SCI-PANSS (structured clinical interview - for the Positive and Negative Syndrome Scale).'}, {'measure': 'Duration of schizophrenia', 'timeFrame': 'Baseline', 'description': 'Duration of schizophrenia as determined from self reported year of first episode of diagnosis/ or from date of diagnosis'}, {'measure': 'Length of treatment with an antipsychotic medication', 'timeFrame': 'Baseline', 'description': 'The length of treatment with an antipsychotic medication will be reported in years'}, {'measure': 'Antipsychotic dosage in daily equivalent dosage of chlorpromazine', 'timeFrame': 'Baseline', 'description': 'Antipsychotic dosages will also be converted to daily equivalent dosage of chlorpromazine for comparison across different medication will be reported in mg/day'}, {'measure': 'Smoking status', 'timeFrame': 'Baseline', 'description': 'Number of participants who smoke will be reported in percent (%)'}, {'measure': 'Waist Hip Ratio', 'timeFrame': 'Baseline', 'description': 'Waist Hip measurements will be reported as a ratio'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline', 'description': 'Body Mass Index, BMI will be derived from participants weight and height and reported as kg/m\\^2'}, {'measure': 'Body fat percent', 'timeFrame': 'Baseline', 'description': 'Body fat percent from body composition analysis will be reported in %'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline', 'description': 'Baseline physical activity measured using the International Physical Activity Questionnaire (IPAQ) The IPAQ is validated in schizophrenia populations and the IPAQ has been validated in Norwegian populations. It is a self reported scoring system assessing physical activity over the last seven days. Physical activity can be then represented in minutes/week or MET-minutes/week.'}, {'measure': 'Body muscle composition', 'timeFrame': 'Baseline', 'description': 'Body muscle mass will be reported in kg'}, {'measure': 'Smoking history', 'timeFrame': 'Baseline', 'description': 'Smoking will be quantified and reported as pack/years'}, {'measure': 'Age of participant', 'timeFrame': 'Baseline', 'description': 'Age of participant will be reported in years'}, {'measure': 'Gender of participant', 'timeFrame': 'Baseline', 'description': 'Gender of participant will be reported as male or female'}], 'primaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography', 'timeFrame': 'Baseline', 'description': "Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography."}, {'measure': 'Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography', 'timeFrame': 'Baseline', 'description': 'Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography'}, {'measure': 'DISC1 mRNA quantification', 'timeFrame': 'Baseline', 'description': 'Measured from blood samples and reported as fold change'}, {'measure': 'Levels of high sensitive-CRP', 'timeFrame': 'Baseline', 'description': 'Levels of HS-CRP mg/L'}, {'measure': 'Levels of CK-MB', 'timeFrame': 'Baseline', 'description': 'Levels of CK-MB is reported in µg/L'}, {'measure': 'Levels of Troponin T', 'timeFrame': 'Baseline', 'description': 'Levels of Troponin T is reported in ng/L'}, {'measure': 'Levels of Troponin I', 'timeFrame': 'Baseline', 'description': 'Levels of Troponin I is reported in ng/L'}, {'measure': 'Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter', 'timeFrame': 'Baseline', 'description': 'LV EDV in milliliters (mL) will be normalized against body surface area (BSA) in m\\^2 to report LV EDV normalized by BSA in mL/m\\^2.'}, {'measure': 'Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter', 'timeFrame': 'Baseline', 'description': 'RV EDV in mL will be normalized against body surface area (BSA) in m\\^2 to report RV EDV normalized by BSA in mL/m\\^2.'}, {'measure': 'Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter', 'timeFrame': 'Baseline', 'description': 'LV ESV in mL will be normalized against body surface area (BSA) in m\\^2 to report LV ESV normalized by BSA in mL/m\\^2.'}, {'measure': 'Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter', 'timeFrame': 'Baseline', 'description': 'RV ESV in mL will be normalized against body surface area (BSA) in m\\^2 to report RV ESV normalized by BSA in mL/m\\^2.'}, {'measure': 'Left ventricular mass measured by echocardiography', 'timeFrame': 'Baseline', 'description': 'Left ventricular mass in grams (g) will be normalized against BSA in m\\^2 and reported as g/m \\^2'}, {'measure': 'Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography', 'timeFrame': 'Baseline', 'description': 'Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)'}, {'measure': 'Fractional shortening measured by echocardiography', 'timeFrame': 'Baseline', 'description': 'Fractional shortening will be reported as a percentage (%)'}, {'measure': 'Global longitudinal strain (GLS), echocardiographic parameter', 'timeFrame': 'Baseline', 'description': 'GLS(%) = (MLs - MLd)/MLd, where MLs is myocardial length at end-systole and MLd is the myocardial length at end-diastole. GLS will be reported in precentage (%)'}, {'measure': 'TAPSE echocardiographic parameter of right ventricular longitudinal systolic function', 'timeFrame': 'baseline', 'description': 'TAPSE will be reported in millimeters (mm)'}, {'measure': 'Echocardiographic parameter MPI, Myocardial performance index', 'timeFrame': 'Baseline', 'description': 'MPI is a unitless index derived from the sum of the isovolumic relaxation time (IVRT) and the isovolumic contraction time (IVCT) in milliseconds (ms) divided by the ejection time interval in (ms).'}, {'measure': 'Echocardiographic parameter Mitral E/A ratio', 'timeFrame': 'Baseline', 'description': 'Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity'}, {'measure': 'Echocardiography parameter of peak E velocity', 'timeFrame': 'Baseline', 'description': 'peak E velocity is reported in cm/s'}, {'measure': 'Echocardiography parameter of E wave deceleration time', 'timeFrame': 'Baseline', 'description': 'E wave deceleration time is reported in milliseconds (ms)'}, {'measure': "Echocardiography parameter of ratio of E/e'", 'timeFrame': 'Baseline', 'description': "The E/e' ratio is derived from the E wave velocity to the e' velocity"}, {'measure': "Echocardiographic parameters septal e' and lateral e' velocities", 'timeFrame': 'Baseline', 'description': "Septal e' and lateral e' velocities are reported as cm/s"}, {'measure': 'Echocardiographic parameter LAVI, left atrial volume indexed', 'timeFrame': 'Baseline', 'description': 'LAVI is reported in mL/m\\^2 and is the volume (mL) of the left atrium indexed against the BSA in m\\^2.'}, {'measure': 'Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity', 'timeFrame': 'Baseline', 'description': 'TRpV is reported in m/s'}, {'measure': 'Echocardiographic parameter, S wave velocity', 'timeFrame': 'Baseline', 'description': 'S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s'}, {'measure': 'Echocardiographic parameter, Indexed LV and RV stroke volumes', 'timeFrame': 'Baseline', 'description': 'Indexed LV stroke volume and Indexed RV stroke volume will be reported in mL/m\\^2 by by indexing the volumes (mL) to BSA (m\\^2)'}, {'measure': 'Levels of NT-proBNP', 'timeFrame': 'Baseline', 'description': 'Levels of NT-proBNP from blood samples will be reported in ng/L'}, {'measure': 'Levels of IGF1', 'timeFrame': 'Baseline', 'description': 'Levels of IGF1 from blood samples will be reported in nmol/L'}, {'measure': 'Levels of ANP', 'timeFrame': 'Baseline', 'description': 'Levels of ANP from blood samples will be reported in pg/mL'}, {'measure': 'Levels of BDNF, brain derived neurotrophic factor', 'timeFrame': 'Baseline', 'description': 'Levels of BDNF from blood samples will be reported in ng/mL'}, {'measure': 'Levels of Tumor Necrosis Factor alpha', 'timeFrame': 'Baseline', 'description': 'Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL'}, {'measure': 'Levels of Transforming Growth Factor Beta', 'timeFrame': 'Baseline', 'description': 'Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL'}, {'measure': 'Levels of cardiac Myosin-Binding Protein C', 'timeFrame': 'Baseline', 'description': 'Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L'}, {'measure': 'Interleukin levels', 'timeFrame': 'Baseline', 'description': 'Interleukin levels from blood sample will be reported as pg/mL'}], 'secondaryOutcomes': [{'measure': 'native T1 time, cardiac MRI', 'timeFrame': 'Baseline', 'description': 'native myocardial T1 relaxation time is reported in milliseconds (ms)'}, {'measure': 'Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI', 'timeFrame': 'Baseline', 'description': 'Indexed LV and RV end-diastolic, end-systolic and stroke volumes will be reported in mL/m\\^2, by indexing the volumes (mL) to BSA (m\\^2)'}, {'measure': 'Indexed LV mass, cardiac MRI', 'timeFrame': 'Baseline', 'description': 'Indexed LV mass will be reported in g/m\\^2 by indexing mass (g) to BSA (m\\^2)'}, {'measure': 'LV Ejection Fraction, cardiac MRI', 'timeFrame': 'Baseline', 'description': 'LVEF will be reported in percent (%)'}, {'measure': 'ECG corrected QT interval', 'timeFrame': 'Baseline', 'description': 'corrected QT interval will be reported in milliseconds (ms)'}, {'measure': 'Number of participants with and abnormal ECG', 'timeFrame': 'Baseline', 'description': 'Number of participants with an abnormal ECG will be reported in %'}, {'measure': 'Number of participants with abnormal liver function', 'timeFrame': 'Baseline', 'description': 'Number of participants with abnormal liver function will be reported as %'}, {'measure': 'Number of participants with abnormal kidney function', 'timeFrame': 'Baseline', 'description': 'Number of participants with abnormal kidney function will be reported as %'}, {'measure': 'Number of participants with abnormal thyroid function', 'timeFrame': 'Baseline', 'description': 'Number of participants with abnormal thyroid function will be reported as %'}, {'measure': 'Number of participants with low Vitamin D levels', 'timeFrame': 'Baseline', 'description': 'Number of participants with low Vitamin D levels will be reported as %'}, {'measure': 'Incidence of cardiovascular disease or mortality as registered in a health registry on follow up', 'timeFrame': 'Within 15 years from start of study', 'description': 'Extraction of information from the cardiovascular disease registry and deaths registry between 10 - 15 years from the start of the study to determine incidence of cardiovascular disease outcomes for the study cohort'}, {'measure': 'Triglyceride levels', 'timeFrame': 'Baseline', 'description': 'Triglyceride will be reported in mmol/L'}, {'measure': 'High-density lipoprotein, HDL-cholesterol levels', 'timeFrame': 'Baseline', 'description': 'HDL-cholesterol levels will be reported in mmol/L'}, {'measure': 'Low-density lipoprotein, LDL-cholesterol levels', 'timeFrame': 'Baseline', 'description': 'LDL-cholesterol levels will be reported in mmol/L'}, {'measure': 'Fasting glucose levels', 'timeFrame': 'Baseline', 'description': 'Fasting glucose levels will be reported in mmol/L'}, {'measure': 'Glycated Hemoglobin (HbA1c) levels', 'timeFrame': 'Baseline', 'description': 'HbA1C will be reported in mmol/mol'}, {'measure': 'Heart rate measured on ECG', 'timeFrame': 'Baseline', 'description': 'Heart rate measured on 12 lead ECG will be reported in beats per minute.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline', 'description': 'Systolic Blood Pressure will be reported as mmHg'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline', 'description': 'Diastolic Blood Pressure will be reported as mmHg'}, {'measure': 'Lipoprotein a', 'timeFrame': 'Baseline', 'description': 'Lipoprotein a levels will be reported in mg/L'}, {'measure': 'Magnesium levels', 'timeFrame': 'Baseline', 'description': 'Magnesium levels will be reported as mmol/L'}, {'measure': 'Calcium levels', 'timeFrame': 'Baseline', 'description': 'Calcium levels will be reported as mmol/L'}, {'measure': 'Sodium levels', 'timeFrame': 'Baseline', 'description': 'Sodium levels will be reported as mmol/L'}, {'measure': 'Potassium levels', 'timeFrame': 'Baseline', 'description': 'Potassium levels will be reported as mmol/L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disrupted in Schizophrenia 1', 'DISC1', 'Cardiac Biomarker'], 'conditions': ['Heart Diseases', 'Heart; Functional Disturbance', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.', 'detailedDescription': 'Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort with schizophrenia will be recruited from outpatient and inpatient population from a single centre.\n\nThe cohort without mental health diagnosis will be selected from an existing population registered in the HUNT data and biobank and be matched for age (± 2 years) and sex of the patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)\n* Both inpatient and outpatient\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* Current or previous diagnosis of cancer\n* Current or previous treatment with chemotherapy\n* Current pregnancy\n* Mothers less than 6 months post-partum'}, 'identificationModule': {'nctId': 'NCT06304233', 'briefTitle': 'The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - The Link Between DISC1 and Cardiac Function in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '606103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnosed with Schizophrenia', 'description': 'Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography.', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Cardiac Magnetic Resonance Imaging', 'Diagnostic Test: Electrocardiography', 'Other: Blood sampling']}, {'label': 'No mental health diagnosis', 'description': 'Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study.', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Cardiac Magnetic Resonance Imaging', 'Diagnostic Test: Electrocardiography', 'Other: Blood sampling']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Echo'], 'description': 'ultrasound assessment of heart structure, volume and function', 'armGroupLabels': ['Diagnosed with Schizophrenia', 'No mental health diagnosis']}, {'name': 'Cardiac Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cardiac MRI', 'CMRI'], 'description': 'MRI assessment of heart structure, volume, function and tissue characteristics', 'armGroupLabels': ['Diagnosed with Schizophrenia', 'No mental health diagnosis']}, {'name': 'Electrocardiography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Holter', 'ECG'], 'description': 'Assessment of cardiac rhythm and electrical activity', 'armGroupLabels': ['Diagnosed with Schizophrenia', 'No mental health diagnosis']}, {'name': 'Blood sampling', 'type': 'OTHER', 'description': 'To measure DISC1 mRNA expression and other potential biomarkers', 'armGroupLabels': ['Diagnosed with Schizophrenia', 'No mental health diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital, Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Morten A Høydal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'During the whole project period up to 15 years.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the study, after deidentification can be shared.', 'accessCriteria': 'For cooperative research and publication within Norway, the EU and the US, for purposes inline with those in the Study protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}