Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-04-21 @ 9:57 PM
Study NCT ID:
NCT02396966
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-03-18', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acromegaly quality of life (AcroQol) questionnaire', 'timeFrame': 'Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)', 'description': 'The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.'}], 'secondaryOutcomes': [{'measure': 'Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration', 'timeFrame': 'Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)', 'description': 'Descriptive analysis'}, {'measure': 'Clinical symptoms of acromegaly', 'timeFrame': 'Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)', 'description': 'Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling'}, {'measure': 'Patient overall assessment of satisfaction from treatment', 'timeFrame': 'Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)', 'description': 'Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied.'}, {'measure': 'Lanreotide injection interval (28, 42 or 56 days)', 'timeFrame': 'Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)', 'description': 'Summary of overall and by hormone control status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Specialist care clinic and hospital clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.\n* Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.\n\nExclusion Criteria:\n\n* Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).\n* Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT02396966', 'acronym': 'ACRO QLQ', 'briefTitle': 'Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.', 'orgStudyIdInfo': {'id': 'A-38-52030-306'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Bytom', 'country': 'Poland', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gliwice', 'country': 'Poland', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Kielce', 'country': 'Poland', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Olsztyn', 'country': 'Poland', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Opole', 'country': 'Poland', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Rybnik', 'country': 'Poland', 'geoPoint': {'lat': 50.09713, 'lon': 18.54179}}, {'city': 'Rzeszów', 'country': 'Poland', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}