Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-20 @ 10:28 AM
Study NCT ID:
NCT02644993
Status:
UNKNOWN
Last Update Posted:
2016-10-14
First Post:
2015-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2015-12-28', 'studyFirstSubmitQcDate': '2015-12-31', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Questionnaire', 'timeFrame': 'within 2 weeks before proton beam therapy'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Questionnaire baseline', 'timeFrame': 'within 1 week before proton beam therapy completion'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': '3-6 months after proton beam therapy'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': '1 year after proton beam therapy'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': '3 years after proton beam therapy'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': '5 years after proton beam therapy'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': '10 years after proton beam therapy'}, {'measure': 'Adverse event', 'timeFrame': '3-6 months after proton beam therapy'}, {'measure': 'Adverse event', 'timeFrame': '1 year after proton beam therapy'}, {'measure': 'Adverse event', 'timeFrame': '3 years after proton beam therapy'}, {'measure': 'Adverse event', 'timeFrame': '5 years after proton beam therapy'}, {'measure': 'Adverse event', 'timeFrame': '10 years after proton beam therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Cancer Patients']}, 'descriptionModule': {'briefSummary': 'The study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less than 18 years of age\n* patient who is planned to receive proton therapy at Samsung Medical Center\n* Informed consent\n\nExclusion Criteria:\n\n* Refuse to participate this cohort study'}, 'identificationModule': {'nctId': 'NCT02644993', 'briefTitle': 'Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'orgStudyIdInfo': {'id': '2015-10-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proton beam therapy', 'interventionNames': ['Radiation: Proton therapy']}], 'interventions': [{'name': 'Proton therapy', 'type': 'RADIATION', 'armGroupLabels': ['Proton beam therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Do Hoon Lim, MD, PhD', 'role': 'CONTACT', 'email': 'dh8.lim@samsung.net', 'phone': '82-2-3410-2612'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Do Hoon Lim, MD, PhD', 'role': 'CONTACT', 'email': 'dh8.lim@samsung.net', 'phone': '82-2-3410-2612'}, {'name': 'Jeong Il Yu, MD', 'role': 'CONTACT', 'email': 'ro.yuji651@gmail.com'}], 'overallOfficials': [{'name': 'Do Hoon Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Proton therapy center, Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Do Hoon Lim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}