Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT07283120
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Breast Surgery on Patients' Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2035-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'up to 10 years', 'description': 'five point likert-scale for satisfaction ( psychometric survey response scale ranging from "Strongly Disagree" to "Strongly Agree". The format includes: 1. Strongly Disagree, 2. Disagree, 3. Neutral (or Neither Agree nor Disagree), 4. Agree, and 5. Strongly Agree Descriptive measures using patient-reported outcome measures (BREAST-Q, McGill short form, EQ-5D-5L)'}, {'measure': 'Patient reported quality of life', 'timeFrame': 'up to 10 years', 'description': 'Descriptive measures using patient-reported outcome measures (BREAST-Q, McGill short form, EQ-5D-5L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators aim to document the surgery-specific and overall Quality of life parameters of patients undergoing all types of breast surgery at the University Hospital of Basel', 'detailedDescription': "The planned ten-year follow-up using Patient reported outcome measure will give us the unique opportunity to gain insight into patients' breast-related QoL (Quality of Life) long after surgery and detect systematic issues that may affect them beyond the scope of routine follow-up consultations. Along with the detection of any occurring adverse events, the information gathered in the database will facilitate the search for risk factors involved in their development, ideally resulting in their rectification and thus contributing to patient well-being in the long term."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent breast surgery at the University Hospital Basel from 2014 onwards', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults who underwent any type of breast surgery at the University Hospital of Basel\n\nExclusion Criteria:\n\n* Patients under the age of 18 years, without general consent or written informed consent, with insufficient language comprehension or other factors limiting their ability to co-operate in the study'}, 'identificationModule': {'nctId': 'NCT07283120', 'briefTitle': "The Impact of Breast Surgery on Patients' Quality of Life", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': "The Impact of Breast Surgery on Patients' Quality of Life", 'orgStudyIdInfo': {'id': '2025-00210; bb25kappos3'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Elisabeth Kappos, Prof.', 'role': 'CONTACT', 'email': 'elisabeth.kappos@usb.ch', 'phone': '+41 61 265 25 25'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Elisabeth Kappos, Prof.', 'role': 'CONTACT', 'email': 'elisabeth.kappos@usb.ch', 'phone': '+4161 265 25 25'}], 'overallOfficials': [{'name': 'Elisabeth Kappos, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}