Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-27 @ 9:48 AM
Study NCT ID:
NCT05042557
Status:
UNKNOWN
Last Update Posted:
2021-09-13
First Post:
2021-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Study of MPM in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-05', 'studyFirstSubmitDate': '2021-09-05', 'studyFirstSubmitQcDate': '2021-09-05', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2-year overall survival', 'description': 'Overall survival is defined as the time from diagnosis to death for any reason or last follow-up'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2-year progression-free survival', 'description': 'Progression-free survival is defined as the time from diagnosis to the first event of progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MPM', 'Prognosis', 'Radiotherapy'], 'conditions': ['Malignant Pleural Mesothelioma', 'Diagnoses Disease', 'Treatments', 'Prognosis']}, 'descriptionModule': {'briefSummary': 'Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China.\n\nFocusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were pathologically confirmed as malignant pleural mesothelioma is included in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed as malignant pleural mesothelioma\n* Aged over 18\n\nExclusion Criteria:\n\n* Follow-up less than 3 months'}, 'identificationModule': {'nctId': 'NCT05042557', 'briefTitle': 'Real World Study of MPM in China', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Real World Study of Diagnosis, Treatment and Prognosis of Malignant Pleural Mesothelioma in China', 'orgStudyIdInfo': {'id': 'NCC202062402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sun Yat-sen University Cancer Center'}, {'label': 'hanghai Chest Hospital'}, {'label': 'Tianjin Cancer Hospital'}, {'label': 'Fudan University Shanghai Cancer Center'}, {'label': 'Anhui Cancer Hospital'}, {'label': 'Shandong Cancer Hospital'}, {'label': 'Hunan Cancer Hospital'}, {'label': 'Yunnan Cancer Hospital'}, {'label': 'Chinese Academy of Medical Sciences'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhouguang Hui, M.D.', 'role': 'CONTACT', 'email': 'drhuizg@163.com', 'phone': '8610-87787230'}, {'name': 'Zhouguang Hui, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhouguang Hui, Ph.D.', 'role': 'CONTACT', 'email': 'drhuizg@163.com', 'phone': '861067781331'}], 'overallOfficials': [{'name': 'Zhouguang Hui, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Zhouguang Hui, M.D.', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}