Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-05-13 @ 5:30 PM
Study NCT ID:
NCT03233360
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2533}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'From treatment initiation for advanced or metastatic HCC to the first date of disease progression or death due to any cause, whichever occurred first, up to 2 years', 'description': 'Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date'}, {'measure': 'Time to progression', 'timeFrame': 'From the start of treatment for a disease until disease progression, up to 2 years', 'description': 'Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.'}, {'measure': 'Overall Survival Rate', 'timeFrame': '5 years from date of diagnosis', 'description': 'The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.'}, {'measure': 'Best Overall Response Rate (BORR)', 'timeFrame': 'From treatment initiation to CR or PR, up to 2 years', 'description': 'The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From treatment initiation to SD, CR or PR, up to 2 years', 'description': 'The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'From the time from completing adjuvant/neoadjuvant treatment to the date of HCC recurrence, or the date of death due to any cause, whichever occurred first, up to 2 years', 'description': 'Patients lost for follow up will be censored at the last disease assessment date; DFS rate at 2 years - defined as the proportion of HCC patients who are alive and cancer free 2 years after completion of adjuvant/neoadjuvant treatment'}, {'measure': 'Recurrence rate', 'timeFrame': 'From the time from a CR to treatment to the first recurrence of HCC, up to 2 years', 'description': 'The proportion of patients who experience a recurrence of HCC after having had a CR to treatment'}, {'measure': 'Sites of recurrence', 'timeFrame': 'From the time from a CR to treatment to the first recurrence of HCC, up to 2 years', 'description': 'local/ regional / distant; specify site(s)'}, {'measure': 'Time to treatment recurrence', 'timeFrame': 'From the time from a CR to treatment to the first recurrence of HCC, up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': "The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male aged 21 or above.\n* Patient with confirmed diagnosis of HCC between 1st January 2013 and 31st December 2019 based on one or more of the following criteria:\n\n * American Association for the Study of Liver Diseases (AASLD) criteria\n * Asian Pacific Association for the Study of the Liver (APASL) criteria\n * Histology/cytology\n * Space occupying lesion in the liver and an serum alpha-feto protein of \\> 400 ng/mL in a patient with chronic viral hepatitis or cirrhosis from any cause\n* Informed consent form (ICF) to be presented and signed by patients who are still alive at the point of study enrolment, per local regulations. For the collection of data for deceased subjects, appropriate waiver of consent as per local regulations and guidelines will have to be in place.\n* Patient who is being followed-up at the participating site.\n\nExclusion Criteria:\n\n\\- Patients participating in any HCC-related therapeutic/interventional clinical trial.'}, 'identificationModule': {'nctId': 'NCT03233360', 'acronym': 'INSIGHT', 'briefTitle': 'Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry', 'orgStudyIdInfo': {'id': 'AHCC08 INSIGHT'}}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': 'SA 5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Southwest Hospital of Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Medical University Cancer Center', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Bayi Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '589-8511', 'city': 'Ōsakasayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kinki University School of Medicine'}, {'zip': '104-0045', 'city': 'Chūōku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Centre, Japan'}, {'zip': '181-8611', 'city': 'Mitaka-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin University School of Medicine'}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'University of Tokyo', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '1023', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '16247', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'St Vincent Hospital, Catholic University Medical College', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '16499', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Centre', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '131-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '40402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital-KS', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10210', 'city': 'Bang Khen', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulabhorn Hospital', 'geoPoint': {'lat': 13.87741, 'lon': 100.6255}}, {'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}, {'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'Pierce Chow, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group', 'class': 'UNKNOWN'}, {'name': 'Singapore Clinical Research Institute', 'class': 'OTHER'}, {'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}