Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 4:36 PM
Study NCT ID:
NCT01978756
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'As part of the study a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank. The purpose to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.\n\nFor detailed information: ClinicalTrials.gov Identifier: NCT01084785'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'In addition, we will record potential risk factors for the several outcome parameters', 'timeFrame': 'one consultation by physician (assistant) ten years after radiotherapy', 'description': 'The following the potential risk factors are recorded:\n\n1. Patient related risk factors:\n\n * Age at time of diagnosis\n * Genetic and protein profile blood samples (optional with informed consent of participant)\n * Smoking\n2. Treatment related factors:\n\n * Type of surgery\n * Excision volume\n * Post-operative complications\n * Resection margins Free\n * Scar visibility\n * Axillary surgery\n * Radiotherapy\n * Fractionation scheme\n * Target volumes\n * Dose-volume parameters\n * Actually delivered dose\n * Chemotherapy\n * Hormonal treatment\n * Immunotherapy\n3. Tumor related factors\n\n * Localization\n * Stage\n * Differentiation grade\n * Hormonal receptors\n * HER-2\n * Genetic profile'}], 'primaryOutcomes': [{'measure': 'The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.', 'timeFrame': 'One assessment approximately 10 years after radiotherapy', 'description': 'As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \\[Barnett et al, 2012\\].'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.', 'timeFrame': 'One assessment approximately 10 years after radiotherapy', 'description': 'The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Outpatient clinic', 'Breast cancer', 'Late toxicity'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.\n\nThere are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.\n\nThe second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.\n\nThe ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are all patients who have been treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003. They will be retrieved from the appointment -IT system. For all these patients will be checked whether they are alive using the MBA (municipal base administration).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.\n* Consent to invitation letter and willing to participate.\n\nExclusion Criteria:\n\n* Treatment without curative intent.\n* No consent to invitation letter'}, 'identificationModule': {'nctId': 'NCT01978756', 'briefTitle': 'Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.', 'orgStudyIdInfo': {'id': '12-25-15/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatient clinic', 'description': 'All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic. These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome. In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment. Patients are seen by a physician or a physician assistant at the outpatient clinic.', 'interventionNames': ['Other: Outpatient clinic']}], 'interventions': [{'name': 'Outpatient clinic', 'type': 'OTHER', 'description': 'The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.', 'armGroupLabels': ['Outpatient clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 XW', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'MAASTRO clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Liesbeth J Boersma, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastro Clinic, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}