Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT03410394
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2018-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'samples from tumor specimen. All patients signed a specific and validated form allowing the collection of samples with DNA (CNIL N° DC2014-2114)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications (endocrine surgical procedure)', 'timeFrame': '12 months after surgical procedure', 'description': 'morbidity rate in percentage (%)'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications severity (endocrine surgical procedure)', 'timeFrame': '12 months after surgical procedure', 'description': 'Dindo-Clavien classification in percentage (%)'}, {'measure': 'Postoperative mortality (endocrine surgical procedure)', 'timeFrame': '12 months after surgical procedure', 'description': 'mortality rate in percentage (%)'}, {'measure': 'CT imaging before endocrine surgical procedure (Tumor characteristics)', 'timeFrame': 'Baseline', 'description': 'Density in Hounsfield unit (HU)'}, {'measure': 'CT imaging before endocrine surgical procedure (Coronary artery score)', 'timeFrame': 'Baseline', 'description': 'CAC score in Agatston score unit (HU)'}, {'measure': 'CT imaging before endocrine surgical procedure (Sarcopenia)', 'timeFrame': 'preoperative period', 'description': 'Evaluation of sarcopenia using L3 skeletal muscle index (in cm²/m²)'}, {'measure': 'Bone mineral density', 'timeFrame': 'Baseline', 'description': 'dual-energy x-ray absorptiometry (DEXA) (in T-score unit)'}, {'measure': 'Intraoperative systolic arterial pressure', 'timeFrame': 'Intraoperative', 'description': 'systolic arterial pressure (in mmHg)'}, {'measure': 'Intraoperative diastolic arterial pressure', 'timeFrame': 'Intraoperative', 'description': 'diastolic arterial pressure (in mmHg)'}, {'measure': 'Parathormone plasma levels', 'timeFrame': 'Baseline and up to 12 months after surgical procedure', 'description': 'Parathormone (in pg/mL)'}, {'measure': 'Aldosterone plasma levels', 'timeFrame': 'Baseline and up to 12 months after surgical procedure', 'description': 'Aldosterone (in pmol/L)'}, {'measure': 'Plasma renin activity', 'timeFrame': 'Baseline and up to 12 months after surgical procedure', 'description': 'Renin (in μIU/mL)'}, {'measure': 'Plasma free metanephrines', 'timeFrame': 'Baseline and up to 12 months after surgical procedure', 'description': 'metanephrines (in nmol/L)'}, {'measure': 'PET scanning', 'timeFrame': 'Baseline', 'description': 'standardized uptake values (SUV tumor / SUV liver ratio)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adrenal', 'thyroid', 'parathyroid', 'endocrine pancreas', 'endocrine digestive tube'], 'conditions': ['Endocrine Tumor']}, 'referencesModule': {'references': [{'pmid': '29998394', 'type': 'DERIVED', 'citation': 'Greilsamer T, Nomine-Criqui C, Thy M, Ullmann T, Zarnegar R, Bresler L, Brunaud L. Robotic-assisted unilateral adrenalectomy: risk factors for perioperative complications in 303 consecutive patients. Surg Endosc. 2019 Mar;33(3):802-810. doi: 10.1007/s00464-018-6346-2. Epub 2018 Jul 11.'}], 'seeAlsoLinks': [{'url': 'https://eurocrine.eu/', 'label': 'EUROCRINE WEB SITE'}]}, 'descriptionModule': {'briefSummary': 'This registry aims to collect informations about patients with endocrine tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) who undergo endocrine surgical procedures. This registry is part of the Eurocrine Project.', 'detailedDescription': 'The EUROCRINE project aims to decrease morbidity and mortality of rare endocrine tumours, by means of a pan-European database. Recording and accessing data at the European level, makes it possible to identify these tumours, which cannot be distinguished at local or national level, because of their extreme rarity. Dissemination of results aims to raise clinical standards and reduce differences in practise between clinics and member states, and thereby diminish morbidity and mortality. Comparison of practice and outcomes will be especially interesting for centres wanting to improve their standards to what is currently considered best practice. EUROCRINE will be a key means by which the medical profession, researchers, health policy makers, and not least patients, can benefit from an increase in knowledge related to diagnosis, treatment, and future clinical research in the field of rare endocrine tumours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who undergo surgical procedures for endocrine tumors at CHU Nancy Brabois (University hospital)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who undergo surgical procedures for endocrine tumors at the University Nancy Brabois Hospital\n\nExclusion Criteria:\n\n* unable to receive clear information\n* refusal to sign the consent form'}, 'identificationModule': {'nctId': 'NCT03410394', 'acronym': 'eurocrine', 'briefTitle': 'Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Registre Tumeurs Endocrine - Eurocrine', 'orgStudyIdInfo': {'id': 'N° CCTIRS :15.291 Version N°3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'registry of endocrine tumors', 'description': '* Patients who undergo thyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-22.\n* Patients who undergo parathyroid surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-23\n* Patients who undergo adrenal surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-24\n* Patients who undergo pancreatic and digestive surgical procedures. This registry was declared at the commission national informatique et libertés (CNIL) with the number R2015-26'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'laurent Brunaud', 'role': 'CONTACT', 'email': 'l.brunaud@chu-nancy.fr'}], 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'laurent Brunaud, MD, PhD', 'role': 'CONTACT', 'email': 'l.brunaud@chru-nancy.fr'}, {'name': 'Brunaud', 'role': 'CONTACT', 'email': 'l.brunaud@chru-nancy.fr'}], 'overallOfficials': [{'name': 'laurent Brunaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'investigator', 'investigatorFullName': 'Laurent BRUNAUD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}