Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04055805
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2019-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-08-10', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results from some questionnaires related to patients QoL, rated from 1 to 10.', 'timeFrame': '26-32 months', 'description': 'Description of the current state of the most frequent clinical and therapeutical approaches to bone diseases in 700 breast cancer menopausal patients treated with adjuvant and/or hormonal therapy. These patients are assessed by questionnaires regarding quality of life, menopausal status and current anti resorptive treatments'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aromatase Inhibitors', 'Bone pathology', 'QoL'], 'conditions': ['Breast Cancer Female', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments', 'genderDescription': 'Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients willing to provide the Informed consent to participate to the study\n* Women aged 18-75 years\n* Patients having breast cancer, with no phenotype restrictions\n* Patients in natural and stable menopause\n* Patients having secondary amenorrhea, that arose after the initiation of oncologic treatment, since at least 12 months or 6 months with FSH\\> 40 U/I\n\nExclusion Criteria:\n\n* Patients with advanced cancer and/or bone metastases and/or visceral metastases\n* Patients with severe renal insufficiency and/or in dialysis and patients affected by severe endocrine disorders'}, 'identificationModule': {'nctId': 'NCT04055805', 'briefTitle': 'Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Health and Quality of Life in Oncological Patients: Management of Bone Pathology in the Italian Citbl (Cancer Treatment Induced Bone Loss) Population', 'orgStudyIdInfo': {'id': 'VIL-HEQ-17-014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fondazione Policlinico Universitario A. Gemelli, Roma', 'description': 'Polo Scienze della Salute della Donna e del Bambino', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Università degli Studi di Pavia', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Università di Napoli "Federico II"', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Università degli Studi di Siena', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Azienda Ospedaliero-Universitaria Careggi Firenze', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Fondazione Policlinico Universitario A. Gemelli Roma', 'description': 'U.O.C Chirurgia Senologica', 'interventionNames': ['Behavioral: Observational Analysis']}, {'label': 'Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale', 'interventionNames': ['Behavioral: Observational Analysis']}], 'interventions': [{'name': 'Observational Analysis', 'type': 'BEHAVIORAL', 'description': 'Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy', 'armGroupLabels': ['Azienda Ospedaliero-Universitaria Careggi Firenze', 'Fondazione Policlinico Universitario A. Gemelli Roma', 'Fondazione Policlinico Universitario A. Gemelli, Roma', 'Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale', 'Università degli Studi di Pavia', 'Università degli Studi di Siena', 'Università di Napoli "Federico II"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Villa, MD, PhD', 'role': 'CONTACT', 'email': 'paola.villa@policlinicogemelli.it', 'phone': '+393392318208'}], 'facility': 'Policlinico Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Paola Villa, Md PhD', 'role': 'CONTACT', 'email': 'paola.villa@policlinicogemelli.it', 'phone': '+393392318208'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr.ssa Paola Villa', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}