Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-26 @ 6:48 PM
Study NCT ID:
NCT05775757
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMC Radiation Oncology Breast Cancer Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cosmesis from baseline', 'timeFrame': 'After 2-3 weeks after the start of radiation therapy (During radiation therapy)', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of cosmesis from baseline', 'timeFrame': '2-3 weeks after the completion of radiation therapy', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of cosmesis from baseline', 'timeFrame': '6 months after radiation therapy', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of cosmesis from baseline', 'timeFrame': '1 year after radiation therapy', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of cosmesis from baseline', 'timeFrame': '2 year after radiation therapy', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of cosmesis from baseline', 'timeFrame': '5 year after radiation therapy', 'description': 'Evaluated by two blinded independent physicians based on photographs'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': 'After 2-3 weeks after the start of radiation therapy (During radiation therapy)', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': '2-3 weeks after the completion of radiation therapy', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': '6 months after radiation therapy', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': '1 year after radiation therapy', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': '2 year after radiation therapy', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of fibrosis from baseline', 'timeFrame': '5 year after radiation therapy', 'description': 'Evaluated using fibrometer measuring both breast'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': 'After 2-3 weeks after the start of radiation therapy (During radiation therapy)', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': '2-3 weeks after the completion of radiation therapy', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': '6 months after radiation therapy', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': '1 year after radiation therapy', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': '2 year after radiation therapy', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Change of patient-reported outcome from baseline', 'timeFrame': '5 year after radiation therapy', 'description': 'BREAST-Q questionnaire is used to evaluate patient-reported outcome.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': 'After 2-3 weeks after the start of radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '2-3 weeks after the completion of radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '6 months after radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '1 year after radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '2 year after radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '5 year after radiation therapy', 'description': 'CTCAE version 4.03 is used to evaluate physician-assessed toxicities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.\n\nThe main question it aims to answer are:\n\n* Changes in breast skin\n* Factors related to breast skin changes\n* Patient-reported outcomes\n* Cosmetic outcomes\n\nParticipants will be assessed by multi-dimensional methods before and after radiotherapy:\n\n* Photographs\n* Fibrometer\n* Questionnaires (BREAST-Q)\n* CTCAE version 4.03 evaluated by treating physicians'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer treated with curative surgery\n\nExclusion Criteria:\n\n* History of thoracic radiation therapy'}, 'identificationModule': {'nctId': 'NCT05775757', 'acronym': 'RASCO', 'briefTitle': 'SMC Radiation Oncology Breast Cancer Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy', 'orgStudyIdInfo': {'id': 'SMC 2021-05-045'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hypofractionated radiation therapy', 'type': 'RADIATION', 'description': 'Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'CONTACT', 'email': 'haeyoung0131.kim@samsung.com', 'phone': '82-2-3410-2612'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'CONTACT', 'email': 'haeyoung0131.kim@samsung.com', 'phone': '82-2-3410-2612'}, {'name': 'Nalee Kim, MD, PhD', 'role': 'CONTACT', 'email': 'rodr.naleekim@gmail.com', 'phone': '82-2-3410-2612'}], 'overallOfficials': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Haeyoung Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}