Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-09 @ 6:05 PM
Study NCT ID:
NCT01777802
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2013-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2013-01-24', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers.', 'timeFrame': 'Before and after SBRT, IMRT, or brachytherapy', 'description': 'Changes in baseline circulating tumor reactive immune markers after radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Breast Cancer', 'Lung Cancer', 'Melanoma']}, 'referencesModule': {'references': [{'pmid': '30205124', 'type': 'DERIVED', 'citation': 'Evans JD, Morris LK, Zhang H, Cao S, Liu X, Mara KC, Stish BJ, Davis BJ, Mansfield AS, Dronca RS, Iott MJ, Kwon ED, Foote RL, Olivier KR, Dong H, Park SS. Prospective Immunophenotyping of CD8+ T Cells and Associated Clinical Outcomes of Patients With Oligometastatic Prostate Cancer Treated With Metastasis-Directed SBRT. Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):229-240. doi: 10.1016/j.ijrobp.2018.09.001. Epub 2018 Sep 8.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (\\>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Oligometastatic prostate, lung, breast and melanoma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer\n\nExclusion Criteria:\n\n-Life expectancy of less than 3 months'}, 'identificationModule': {'nctId': 'NCT01777802', 'acronym': 'SBRT', 'briefTitle': 'Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy', 'orgStudyIdInfo': {'id': '12-008383'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate Cancer', 'description': 'Patients with prostate cancer will be treated with SBRT, IMRT or brachytherapy', 'interventionNames': ['Radiation: SBRT', 'Radiation: IMRT', 'Radiation: Brachytherapy']}, {'label': 'Breast Cancer', 'description': 'Patients with breast cancer will be treated with SBRT, IMRT or brachytherapy', 'interventionNames': ['Radiation: SBRT', 'Radiation: IMRT', 'Radiation: Brachytherapy']}, {'label': 'Lung Cancer', 'description': 'Patients with lung cancer will be treated with SBRT, IMRT or brachytherapy', 'interventionNames': ['Radiation: SBRT', 'Radiation: IMRT', 'Radiation: Brachytherapy']}, {'label': 'Melanoma Cancer', 'description': 'Patients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy', 'interventionNames': ['Radiation: SBRT', 'Radiation: IMRT', 'Radiation: Brachytherapy']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'armGroupLabels': ['Breast Cancer', 'Lung Cancer', 'Melanoma Cancer', 'Prostate Cancer']}, {'name': 'IMRT', 'type': 'RADIATION', 'armGroupLabels': ['Breast Cancer', 'Lung Cancer', 'Melanoma Cancer', 'Prostate Cancer']}, {'name': 'Brachytherapy', 'type': 'RADIATION', 'armGroupLabels': ['Breast Cancer', 'Lung Cancer', 'Melanoma Cancer', 'Prostate Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Sean S Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}