Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT00773656
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2008-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients Overexposed for a Prostate Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'White cells, serum and DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.', 'timeFrame': 'At the inclusion visit'}], 'secondaryOutcomes': [{'measure': 'Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.', 'timeFrame': 'At the inclusion visit'}, {'measure': 'Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity', 'timeFrame': 'At the inclusion visit'}, {'measure': 'Gene associations with risks for adverse events related to radiotherapy', 'timeFrame': 'At the inclusion visit'}, {'measure': 'Levels of circulating microparticles and bystander effect after irradiation', 'timeFrame': 'At the inclusion visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Biologically effective dose', 'Radiation injury'], 'conditions': ['Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '17331670', 'type': 'BACKGROUND', 'citation': 'Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. doi: 10.1016/j.ijrobp.2006.12.050. Epub 2007 Feb 27.'}, {'pmid': '36739457', 'type': 'DERIVED', 'citation': 'Ribault A, Benadjaoud MA, Squiban C, Arnaud L, Judicone C, Leroyer AS, Rousseau A, Huet C, Guha C, Benderitter M, Lacroix R, Flamant S, Chen EI, Simon JM, Tamarat R. Circulating microvesicles correlate with radiation proctitis complication after radiotherapy. Sci Rep. 2023 Feb 4;13(1):2033. doi: 10.1038/s41598-022-21726-y.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nBetween 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.\n\nAim of the study:\n\nTo correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.\n\nPrimary study endpoint:\n\nIncidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).', 'detailedDescription': 'Secondary study endpoint:\n\n* Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.\n* Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity\n* Gene associations with risks for adverse events related to radiotherapy\n* Levels of circulating microparticles and bystander effect after irradiation\n\nInclusion criteria:\n\nConsecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.\n\nPotential. Better identification of patients at high risk of adverse events related to radiotherapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* provision of informed consent\n* patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006\n\nExclusion Criteria:\n\n* No provision of informed consent\n* Patient with disease worsening and in incapacity to move about to CHJM'}, 'identificationModule': {'nctId': 'NCT00773656', 'acronym': 'EPOPA', 'briefTitle': 'Patients Overexposed for a Prostate Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AOM 08234'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients treated for a prostate adenocarcinoma', 'interventionNames': ['Other: Whole blood sample']}], 'interventions': [{'name': 'Whole blood sample', 'type': 'OTHER', 'description': '70 ml per patient for collection of biological sample', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean Marc SIMON, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}