Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-03-13 @ 1:57 PM
Study NCT ID:
NCT02526134
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.', 'timeFrame': 'From inclusion to 12 months follow up', 'description': 'Observing whether there is a significant variation of the area to be irradiated'}], 'secondaryOutcomes': [{'measure': 'Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)', 'timeFrame': 'From inclusion to 12 months follow up', 'description': 'Safety and security are measured by statistical analysis (numbers and percentage for qualitative variables and by average, median, standard deviations and extreme values for quantitative variables.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laying of medical devices (radio opaque markers)'], 'conditions': ['Oesophageal Cancer', 'Rectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr', 'label': 'official web site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.', 'detailedDescription': 'The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed.\n\nTo improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate.\n\nThe marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over the age of 18\n* Rectal cancer diagnosis or esophagus\n* Radiotherapy indication\n* Signed consent to participate\n* Patient affiliated to a social security system or benefiting from such a system\n\nExclusion Criteria:\n\n* Pregnant women, of child-bearing potential, or lactating women\n* Patient deprived of liberty or under supervision of a guardian\n* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons\n* Contra-indication for procedure study (infeasible EUS)\n* Contra-indication for general anesthesia\n* Patient (e) with disorders of hemostasis\n* Patient (e) with portal hypertension'}, 'identificationModule': {'nctId': 'NCT02526134', 'acronym': 'FIDUCOR', 'briefTitle': 'Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum', 'orgStudyIdInfo': {'id': 'FIDUCOR-IPC 2013-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laying of medical devices', 'description': 'radio opaque markers', 'interventionNames': ['Device: radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)']}], 'interventions': [{'name': 'radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)', 'type': 'DEVICE', 'armGroupLabels': ['Laying of medical devices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cook medical laboratory', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}