Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 1:34 AM
Study NCT ID:
NCT00849394
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2009-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Protein in the Urine in Patients Receiving Bevacizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2009-02-20', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.', 'timeFrame': '3-6 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria.', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bevacizumab', 'proteinuria'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '106 patients receiving bevacizumab doses of \\< 10 mg/kg at a rate of 0.5 mg/kg/min in hematology/oncology outpatient clinic. Most of the patients are likely to have advanced stage colon or rectal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years older\n* Patients must be receiving his/her first dose of bevacizumab\n* Patients must sign an informed consent\n\nExclusion Criteria:\n\n* Patients receiving \\> 10 mg/kg doses of bevacizumab'}, 'identificationModule': {'nctId': 'NCT00849394', 'briefTitle': 'Evaluation of Protein in the Urine in Patients Receiving Bevacizumab', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab', 'orgStudyIdInfo': {'id': '07-097'}, 'secondaryIdInfos': [{'id': '122007-001;'}, {'id': 'A07-3423'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Shortened infusions of bevacizumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health and Hospital System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Sachin Shah, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center School of Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sachin Shah, Pharm.D., BCOP', 'oldOrganization': 'Texas Tech University Health Sciences Center School of Pharmacy'}}}}