Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT05149495
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the clinical and biological evolution, after discontinuation of treatment with somatostatin analogues, of acromegalic patients with recurrence after surgery.', 'timeFrame': 'Files analysed retrospectively from January 01, 2000 to September 01, 2021 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acromegaly', 'Pituitary microadenoma', 'Pituitary macroadenoma', 'Somatostatin analogues', 'Hormonal control'], 'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described.\n\nThus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subject (≥18 years old)\n* Having been seen at least once in consultation in the Internal Medicine, Endocrinology and Nutrition department of Hautepierre Hospital\n* Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021\n* In whom biological confirmation of recurrence has been demonstrated\n* Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.\n\nExclusion criteria:\n\n* Subject having expressed opposition to participating in the study\n* Treatment pre and / or post surgery by radiotherapy\n* No recurrence\n* No treatment with a somatostatin analogue for recurrence\n* Subject under guardianship, curatorship or safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05149495', 'acronym': 'STOP-SST', 'briefTitle': 'Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery', 'orgStudyIdInfo': {'id': '8409'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe BALTZINGER, MD', 'role': 'CONTACT', 'email': 'philippe.baltzinger@chru-strasbourg.fr', 'phone': '33 3 88 12 75 82'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}, {'name': 'Philippe BALTZINGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ninon STAHL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Philippe BALTZINGER, MD', 'role': 'CONTACT', 'email': 'philippe.baltzinger@chru-strasbourg.fr', 'phone': '33 3 88 12 75 82'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}], 'overallOfficials': [{'name': 'Philippe BALTZINGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}