Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT05902494
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)', 'timeFrame': 'Up to 5 years', 'description': 'The proportion of participants who have a best overall response (BOR) based on complete response (CR) or partial response (PR). The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the lines of treatment (LOT) prior to the initiation of any subsequent LOT.'}], 'secondaryOutcomes': [{'measure': 'Percentages of IHC0, 1+, 2+, and 3+ participants', 'timeFrame': 'Up to 5 years'}, {'measure': 'Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants', 'timeFrame': 'Up to 5 years'}, {'measure': 'Characteristics of LA/mUC participants', 'timeFrame': 'Up to 5 years'}, {'measure': 'Real-world Overall Survival (rwOS)', 'timeFrame': 'Up to 5 years', 'description': 'Time from the index date to date of death from any cause.'}, {'measure': 'Characteristics of treatment patterns in LA/mUC participants', 'timeFrame': 'Up to 5 years', 'description': 'Agent, reason for change of LOT, surgery, radiotherapy, number of LOT, treatments in each LOT, mean number of LOT, median time to discontinuation of each LOT'}, {'measure': 'rwORR for each subsequent LOT following the index LOT', 'timeFrame': 'Up to 5 years', 'description': 'The proportion of participants who had a real-world BOR based on CR or PR. The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the LOT prior to the initiation of any subsequent LOT.'}, {'measure': 'Real-world Time on Treatment (rwTOT)', 'timeFrame': 'Up to 5 years', 'description': 'Time from the start date of the LOT to the end date of the same LOT for any reason.'}, {'measure': 'Real-world Time to Next Treatment (rwTTNT)', 'timeFrame': 'Up to 5 years', 'description': 'The time from the start date of each LOT to the initiation of the next LOT for any reason.'}, {'measure': 'Real-world Progression Free Survival (rwPFS)', 'timeFrame': 'Up to 5 years', 'description': 'Time from the index date to the first recorded disease progression (radiographically documented and measurable disease or physician assessed response) or death from any cause, before the start of next LOT whichever occurs first.'}, {'measure': 'Real-world Duration of Response (rwDOR)', 'timeFrame': 'Up to 5 years', 'description': 'The duration of time from the first documented CR or PR in the LOT to the first recorded disease progression (radiographically documented and measurable disease or physician-assessed response) or death from any cause before the start of the next LOT, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urothelial Cancer', 'Bladder Cancer', 'HER2 Mutations', 'HER2 Overexpression', 'HER2 Amplification', 'Seattle Genetics'], 'conditions': ['Urothelial Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=SGNDV-003', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health.\n\nParticipants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adults from US and European participating hospitals and physicians' practices with histologically confirmed LA/mUC who initiated therapy after prior progression on platinum-based therapy with or without maintenance avelumab.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.\n* Locally advanced unresectable or metastatic stage disease\n* Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.\n* At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.\n* Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection\n* Radiographically documented and measurable disease progression immediately before index date\n\nExclusion Criteria:\n\n* Any concurrent malignant neoplasm requiring systemic therapy during the study window\n* Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy'}, 'identificationModule': {'nctId': 'NCT05902494', 'briefTitle': 'HER2 and LA/mUC: A Multi-country Chart Review Cohort Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression', 'orgStudyIdInfo': {'id': 'SGNDV-003'}, 'secondaryIdInfos': [{'id': 'C5731003', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94394', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute - School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'ICAHN School of Medicine at Mount Sinai,', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute - School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer Institute Center', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt - Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Chu Bordeaux Hopital Saint Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '06189 Cedex 2', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CHU LYON', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen.', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Foch Hospital', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '47805', 'city': 'Krefeld', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Alexianer Krefeld GmbH', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Hospital Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Stuttgart Hospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seagen, a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}