Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-31 @ 8:00 AM
Study NCT ID:
NCT04555369
Status:
UNKNOWN
Last Update Posted:
2021-07-19
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of ctDNA on Chemotherapy Efficacy for mCRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074141', 'term': 'Circulating Tumor DNA'}], 'ancestors': [{'id': 'D000073888', 'term': 'Cell-Free Nucleic Acids'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004273', 'term': 'DNA, Neoplasm'}, {'id': 'D004247', 'term': 'DNA'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '2 months', 'description': 'the response rate predicted by ct-DNA'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '2 months'}, {'measure': 'Overall survival', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circulating Tumor DNA']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function\n\nExclusion Criteria:\n\npatients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection'}, 'identificationModule': {'nctId': 'NCT04555369', 'briefTitle': 'The Value of ctDNA on Chemotherapy Efficacy for mCRC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA', 'orgStudyIdInfo': {'id': 'mCRC-ctDNA FUSCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ct-DNA', 'description': 'The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.', 'interventionNames': ['Genetic: ct-DNA']}], 'interventions': [{'name': 'ct-DNA', 'type': 'GENETIC', 'otherNames': ['circulating tumor DNA'], 'description': 'The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.', 'armGroupLabels': ['ct-DNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinjia Chang, MD,PhD', 'role': 'CONTACT', 'email': 'iamchangjinjia@163.com'}, {'name': 'Weijian Guo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weijian Guo, phD', 'role': 'CONTACT', 'email': 'iamchangjinjia@163.com', 'phone': '8621-64175590'}, {'name': 'Weijian Guo', 'role': 'CONTACT', 'email': 'iamchangjinjia@163.com', 'phone': '8621-64175590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Fudan University Shanghai Cancer Center', 'investigatorFullName': 'Weijian Guo', 'investigatorAffiliation': 'Fudan University'}}}}