Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT03574116
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate muscle status by CT evaluation of sarcopenia in patients', 'timeFrame': '24 hour after the realization of the MRI', 'description': 'Evaluate the impact of feeding jejunostomy in patients with gastric cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'jejunostomy', 'oesogastric adenocarcinoma', 'scanography'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers.\n\nIn an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy.\n\nInvestigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. Is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject with Stage IB Gastric Cancer and having benefited from the placement or not of a feeding jejunostomy and a control CT performed at the HUS, after the end of the courses of chemotherapy and / or before the surger', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria for inclusion:\n\n* Age 18-80 years\n* Sex: H or F\n* Subject giving their consent for their participation\n* Gastric cancers\n* stage\\> IB\n* whether or not a feeding jejunostomy\n* CT scan performed at the HUS, after the end of the courses of chemotherapy and / or before the surgery.\n\nExclusion criteria:\n\n* antecedent level L3 surgery,\n* psoas hematoma\n* No CT performed at HUS at the end of chemotherapy and / or before surgery\n* Impossibility of giving the subject informed information\n* Subject under the protection of justice\n* Subject under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03574116', 'briefTitle': 'Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?', 'orgStudyIdInfo': {'id': '6808'}}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'email': 'Francis.veillon@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Francis VEILLON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Imagerie 1', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'email': 'Francis.veillon@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}