Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-24 @ 10:35 PM
Study NCT ID:
NCT02310594
Status:
TERMINATED
Last Update Posted:
2022-08-18
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, highly developed, laboratory analyses for tumor-specific immunity will be performed using the white blood cells, while the blood components that are soluble, will be frozen and stored, to be examined at a later time for evidence of molecules of anti-tumor immunity that have been induced by radiation therapy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome measures include changes in tumor-specific immune responses and general immune signature in patients undergoing Radiation Treatment. Reportable endpoints are absolute values of and changes in innate & adaptive immune cells and serum markers.', 'timeFrame': 'The time line of interest covers a baseline, pre-treatment sample as well as mid-treatment and a post-treatment, follow-up sample at 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the effect of radiation therapy on tumor immunity.\n\nOUTLINE:\n\nSamples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult cancer patients undergoing physician directed radiation treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study\n* Received an explanation of the study, including satisfactory answers to all questions related to the proposed research\n* Is undergoing physician directed radiation treatment\n\nExclusion Criteria:\n\n* The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form'}, 'identificationModule': {'nctId': 'NCT02310594', 'briefTitle': 'Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'The Effect of Radiation Therapy on Tumor Immunity', 'orgStudyIdInfo': {'id': '10-001588'}, 'secondaryIdInfos': [{'id': 'NCI-2014-02231', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10-001588-CR-00004', 'type': 'OTHER', 'domain': 'Jonsson Comprehensive Cancer Center'}, {'id': 'Steinberg122308'}, {'id': '09-01-010', 'type': 'OTHER', 'domain': 'Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (blood banking)', 'description': 'Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.', 'interventionNames': ['Other: cytology specimen collection procedure', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'cytology specimen collection procedure', 'type': 'OTHER', 'otherNames': ['cytologic sampling'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Ancillary-Correlative (blood banking)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (blood banking)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael Steinberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}