Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT06557668
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-08-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Treatment With Immunomodulator Plus Cancer Therapies for Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the initial treatment until April 2024'}], 'secondaryOutcomes': [{'measure': 'Progress free survival', 'timeFrame': 'From the initial treatment until April 2024'}, {'measure': 'Tumor response', 'timeFrame': 'From the initial treatment until April 2024'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Astragalus Polysaccharides', 'Survival'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the survival and treatment outcomes among colorectal cancer patients undergoing anti-cancer treatment, both with and without an immunomodulator.', 'detailedDescription': 'Colorectal cancer (CRC) is the third most common cancer worldwide. The clinical outcomes from CRC treatments are often unsatisfactory for the majority of patients. The tumor microenvironment (TME) plays an important role to regulate tumor growth, progression, and metastasis and can limit the efficacy of cancer therapies. Therefore, targeting TME could provide an efficient approach for cancer treatment.\n\nAstragalus Polysaccharide Injection, an immunomodulator, which can stimulate medullary hematopoiesis and enhance immune function. It also can modulate TME. Astragalus Polysaccharide Injection has been approved as a prescription drug for alleviating cancer-related fatigue by the Taiwan Food and Drug Administration (TFDA).\n\nIn this retrospective study, we will collect clinical data and survival status of colorectal cancer patients undergoing anti-cancer treatment from their medical records with and without immunomodulator, Astragalus polysaccharide Injection. It can be used to understand the possible clinical benefit of immunomodulator plus anti-cancer therapies for patients with colorectal cancer, and physicians can refer to these results to give patients the suitable treatment recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20 years and older.\n* Patients who have been given a diagnosis of colorectal cancer.\n* Patients had previously initiated anti-cancer therapies between January 1, 2020, and Apr 30, 2024.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06557668', 'briefTitle': 'Clinical Outcomes of Treatment With Immunomodulator Plus Cancer Therapies for Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Clinical Outcomes of Treatment With Immunomodulator Plus Standard Anti-cancer Therapies for Patients With Colorectal Cancer: A Retrospective Study', 'orgStudyIdInfo': {'id': 'APS-CRC01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer treatment with immunomodulator', 'description': 'CRC patients had previously received cancer therapies along with immunomodulator'}, {'label': 'Cancer treatment without immunomodulator', 'description': 'CRC patients had previously received cancer therapies without immunomodulator'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Chung-Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chou-Chen Chen, M.D.', 'role': 'CONTACT', 'email': 'ccchen24615237@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Chou-Chen Chen', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}