Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 2:11 AM
Study NCT ID:
NCT03958435
Status:
UNKNOWN
Last Update Posted:
2021-07-15
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2019-05-19', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer', 'timeFrame': 'From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.', 'description': 'Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer'}, {'measure': 'Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer', 'timeFrame': 'From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.', 'description': 'Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer'}, {'measure': 'Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer', 'timeFrame': 'From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.', 'description': 'Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Current status', 'Chemotherapy regimen', 'Chemotherapy time', 'Efficacy', 'Safety', 'Adjuvant therapy', 'Stage II-III colon cancer', 'RWS(Real World Study)'], 'conditions': ['Stage II Colon Cancer', 'Stage III Colon Cancer', 'Adjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'Background:\n\n1. . The incidence and mortality of colon cancer are high in China and in the world.\n2. . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.\n\nThe purpose of research:\n\n1. . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.\n2. . Comparison of efficacy and safety of different adjuvant chemotherapy time (\\<3 months vs. \\>=3 months) in high-risk stage II and III colon cancer patients in the real world\n3. . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20000 patients diagnosed with stage II-III colon cancer and undergo radical surgery since January 2010.\n\nThe demographic analysis of this study will include but limited in：\n\n* Demographic characteristics (age, gender, height, weight),\n* Clinical information (Site, TNM(Tumor, regional lymph Node, Metastasis) staging, CEA(Carcinoembryonic Antigen), imaging findings, patient ECOG(Eastern Cooperative Oncology Group)score, PS(Performance Status) score),\n* Pathology information (MMR(Mismatch Repair) status, RAS status, BRAF status, HER2 status, Lymph node, Number of detections, Nerve infiltration, Vascular invasion, Histological type, etc.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are sick after January 2010\n* Age is older than 18\n* Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer\n\nExclusion Criteria:\n\n* Combine other tumors\n* Pathological information is not clear\n* Researchers believe that other reasons are not suitable for enrollment'}, 'identificationModule': {'nctId': 'NCT03958435', 'briefTitle': 'Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery', 'orgStudyIdInfo': {'id': 'REDUCE201809'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanhong Gu, MD', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province People Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Changhai Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejinag', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Yuan, Ph.D & MD', 'role': 'CONTACT', 'email': 'yuanying1999@zju.edu.cn'}, {'name': 'Ying Yuan', 'role': 'CONTACT', 'email': 'yuanying1999@zju.edu.cn'}], 'facility': 'SAHZU', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ying Yuan, Ph.D&MD', 'role': 'CONTACT', 'email': 'yuanying1999@zju.edu.cn', 'phone': '+86-571-87784795'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}