Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-27 @ 10:02 AM
Study NCT ID:
NCT01050504
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA genomic sequencing', 'timeFrame': 'Up to 6 years'}, {'measure': 'Gene expression profile using microarray assays', 'timeFrame': 'Up to 6 years'}, {'measure': 'Mutation mapping using the OncoMap and other genotyping techniques', 'timeFrame': 'Up to 6 years'}], 'secondaryOutcomes': [{'measure': 'Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction', 'timeFrame': 'Up to 6 years'}, {'measure': 'Proteomic profile', 'timeFrame': 'Up to 6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Localized Renal Pelvis and Ureter Urothelial Carcinoma', 'Malignant Solid Neoplasm', 'Metastatic Malignant Neoplasm in the Bone', 'Metastatic Malignant Neoplasm in the Soft Tissues', 'Metastatic Renal Pelvis and Ureter Urothelial Carcinoma', 'Recurrent Bladder Carcinoma', 'Recurrent Prostate Carcinoma', 'Recurrent Renal Pelvis and Ureter Urothelial Carcinoma', 'Stage IV Bladder Cancer AJCC v7', 'Stage IV Bladder Urothelial Carcinoma AJCC v7', 'Stage IV Prostate Cancer AJCC v7']}, 'descriptionModule': {'briefSummary': 'This study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.', 'detailedDescription': 'OUTLINE:\n\nPatients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with prostate or bladder/urothelial cancer treated in genitourinary oncology practices at University of Washington Medical Center, Seattle Cancer care Alliance and Harborview Medical Center and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Ability to adequately understand and give informed consent\n* Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study\n* Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Platelet count \\> 50,000\n* White blood cell (WBC) \\> 1,500\n* Hemoglobin (Hgb) \\> 8.0\n* International normalized ratio (INR) \\< 1.5\n* Partial thromboplastin time (PTT) \\< 45\n* No history of excessive unexplained bleeding from previous surgery\n\nExclusion Criteria:\n\n* Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days\n* Serious or uncontrolled infection\n* Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days'}, 'identificationModule': {'nctId': 'NCT01050504', 'briefTitle': 'Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy', 'orgStudyIdInfo': {'id': '6932'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01087', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '6932p'}, {'id': '6932', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'RG1712006', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P50CA097186', 'link': 'https://reporter.nih.gov/quickSearch/P50CA097186', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-correlative (blood and tissue collection)', 'description': 'Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.', 'interventionNames': ['Other: Cytology Specimen Collection Procedure', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Cytology Specimen Collection Procedure', 'type': 'OTHER', 'otherNames': ['Cytologic Sampling'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-correlative (blood and tissue collection)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-correlative (blood and tissue collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert B. Montgomery', 'role': 'CONTACT', 'email': 'rbmontgo@uw.edu', 'phone': '206-598-0856'}, {'name': 'Robert B. Montgomery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Robert B. Montgomery', 'role': 'CONTACT', 'email': 'rbmontgo@uw.edu', 'phone': '206-598-0856'}], 'overallOfficials': [{'name': 'Robert B. Montgomery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}