Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-14 @ 1:17 AM
Study NCT ID:
NCT02070328
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '25 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term follow-up', 'timeFrame': '6 months', 'description': 'Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.'}], 'secondaryOutcomes': [{'measure': 'Future Research Possibilities', 'timeFrame': '12 months', 'description': 'Performing retrospective research studies on diseases treated with proton therapy throughout the United States.\n\nPermitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proton Therapy', 'Registry'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://provisionproton.com', 'label': 'Provision Center for Proton Therapy'}]}, 'descriptionModule': {'briefSummary': "Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Checking on the progress of patients over many years (called long-term follow-up) is needed because the long-term effects of proton therapy are not well known.", 'detailedDescription': 'The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of:\n\n1. Performing retrospective research studies on diseases treated with proton therapy throughout the United States.\n2. Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.\n3. Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are seen/treated at proton therapy centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects who are receiving or seeking medical care at the participating Proton Therapy Center will be invited to participate in the Research Registry.\n\nExclusion Criteria:\n\n* Subjects who do not agree to participate'}, 'identificationModule': {'nctId': 'NCT02070328', 'acronym': 'Registry', 'briefTitle': 'Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Center for Biomedical Research, LLC'}, 'officialTitle': 'Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up', 'orgStudyIdInfo': {'id': 'PRO 0425'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiation therapy Registry', 'description': 'Cancer patients who have received proton therapy', 'interventionNames': ['Other: Registry']}], 'interventions': [{'name': 'Registry', 'type': 'OTHER', 'armGroupLabels': ['Radiation therapy Registry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele Katz, CRC', 'role': 'CONTACT', 'email': 'michelek@ackermancancer.com', 'phone': '904-880-5522'}, {'name': 'Cate Bernatt, CRA', 'role': 'CONTACT', 'email': 'cateb@ackermancancer.com', 'phone': '904-880-5522'}], 'facility': 'Ackerman Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristi Simcox, BS, CCRP', 'role': 'CONTACT', 'email': 'kristi.simcox@biomed-research.com', 'phone': '865-934-2672'}, {'name': 'James Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Provision CARES Proton Therapy Nashville', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '75063', 'city': 'Irving', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanetta G. Zollicoffer, CCRC', 'role': 'CONTACT', 'email': 'Vanetta.Zollicoffer@usoncology.com', 'phone': '469-513-5531'}, {'name': 'Andrew K. Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Center for Proton Therapy', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}], 'centralContacts': [{'name': 'Kristi Simcox, BS, CCRP', 'role': 'CONTACT', 'email': 'kristi.simcox@biomed-research.com', 'phone': '(865) 934-2672'}, {'name': 'James R Gray, M.D.', 'role': 'CONTACT', 'email': 'james.gray@provisionproton.com', 'phone': '(865) 934-2672'}], 'overallOfficials': [{'name': 'James R Gray, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Provision Center for Proton Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Biomedical Research, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Provision Center for Proton Therapy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}