Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 9:52 PM
Study NCT ID:
NCT00026650
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2001-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12-16', 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2001-11-14', 'studyFirstSubmitQcDate': '2001-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the late effects of treatment and the natural history of disease', 'timeFrame': 'Ongoing', 'description': 'Description of late effects of radiation treatment and the natural history of diseases being studied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Late Effects', 'Radiation Therapy', 'Cancer', 'Natural History'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2000-C-0074.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'BACKGROUND\n\n* This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.\n* It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,\n\nintraoperative radiotherapy, etc.\n\nOBJECTIVE\n\n-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.\n\nELIGIBILITY\n\n-Participants who received radiation therapy.\n\nDESIGN\n\n* This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.\n* It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.', 'detailedDescription': 'BACKGROUND\n\n* This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.\n* It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,\n\nintraoperative radiotherapy, etc.\n\nOBJECTIVE\n\n-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.\n\nELIGIBILITY\n\n-Participants who received radiation therapy.\n\nDESIGN\n\n* This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.\n* It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received radiation', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nROB investigator deems that it is in the best interests of the participant and the NCI/ROB for the participant to be seen in follow-up in the ROB clinic.\n\nParticipant is able to provide informed consent.\n\nParticipant must have a primary physician in the community to whom records and appropriate follow-up management can be given. Social services will be enlisted for any participants who lack health insurance, etc.\n\nParticipants who have received radiotherapy.\n\nAge greater than or equal to 18 years of age\n\nEXCLUSION CRITERIA:\n\nParticipants who are on an interventional research protocol at NIH at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT00026650', 'briefTitle': 'Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy', 'nctIdAliases': ['NCT00436813'], 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy', 'orgStudyIdInfo': {'id': '000074'}, 'secondaryIdInfos': [{'id': '00-C-0074'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1/Cohort 1', 'description': 'Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Theresa C Cooley Zgela, R.N.', 'role': 'CONTACT', 'email': 'theresa.cooleyzgela@nih.gov', 'phone': '(301) 451-8905'}, {'name': 'Kevin A Camphausen, M.D.', 'role': 'CONTACT', 'email': 'camphauk@mail.nih.gov', 'phone': '(240) 760-6205'}], 'overallOfficials': [{'name': 'Kevin A Camphausen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Clinical data available during the study and indefinitely.', 'ipdSharing': 'YES', 'description': 'All IPD recorded in the medical record will be shared with intramural investigators upon request.', 'accessCriteria': 'Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}