Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02891369
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the ascites volume', 'timeFrame': '1 Hour before introduction of bevacizumab', 'description': 'Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab'}], 'secondaryOutcomes': [{'measure': 'Assessment of the TNM classification of the cancer', 'timeFrame': 'Day1', 'description': 'type of cancer, TNM'}, {'measure': 'Assessment of the number of paracentis happened', 'timeFrame': 'Month 12', 'description': 'frequency after paracentesis after the introduction of IP bevacizumab'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractory Malignant Ascites']}, 'descriptionModule': {'briefSummary': 'The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.\n\nConventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.\n\nVEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.\n\nThe efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.\n\nStudies in humans are few and the doses used are not consistent from one study to another.', 'detailedDescription': 'Main objective / secondary:\n\nThe objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.\n\nMethodology :\n\nThis is a retrospective study mono centric and non-interventional. data collected\n\n* Name,\n* date of birth,\n* dates and numbers injection of bevacizumab doses\n* side effects,\n* type of cancer, TNM classification,\n* ascites volume collected during paracentesis prior to the introduction of IP bevacizumab,\n* frequency of paracentesis before the introduction of IP bevacizumab,\n* ascites volume collected during paracentesis after the introduction of IP bevacizumab,\n* frequency after paracentesis after the introduction of IP bevacizumab,\n* albumin\n* Number of lines of chemotherapy received\n* Treatment monotherapy or in combination with other chemotherapies\n* WHO Stadium in each course\n* Date of death\n\nsupports\n\n* Data collection from CHIMIO® software DxCare® and non-computerized patient records.\n* Series anonymized patient data on Excel®\n\nCirculation mode and data processing and not opposition patient The anonymous data are entered on a computer file and centralized within the pharmacy department by the investigator of the Groupe Hospitalier Saint Joseph Paris, Carole METZ, to be processed locally.\n\nFor the statistical analysis, quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages. Descriptive data analyzes, correlations between the study variables and more specific tests to determine the prognostic value of variable can be used.\n\nThis is a single-center retrospective cohort within the GHPSJ. Patients are aware of the potential use of their data in their files for medical research by information contained in the handbook of the institution for patients.\n\nDevelopment of the study:\n\n* The list of patients who received bevacizumab injection is obtained from the CHIMIO® software.\n* The data collected is validated by a multidisciplinary way oncologists and pharmacists.\n* Collection and analysis of data by the internal pharmacy from computerized patient records (DxCare®) or not computerized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All assigns patients received at least one injection of bevacizumab intraperitoneal within GHPSJ between 01/01/2007 and 31/12/2014\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02891369', 'acronym': 'BEVASCITE', 'briefTitle': 'Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites', 'orgStudyIdInfo': {'id': 'BEVASCITE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention. Descriptive study', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Meryam JARDIN, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}