Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT03596593
Status:
UNKNOWN
Last Update Posted:
2018-07-24
First Post:
2018-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of MSI-H across different cancer types in Chinese patients', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Incidence of Lynch syndrome across different cancer types', 'timeFrame': 'Two years'}, {'measure': 'Concordance between blood-MSI and corresponding tissue-MSI status', 'timeFrame': 'Two years', 'description': 'In patients who are able to provide tumor tissue samples, concordance between blood-MSI status by SPANOM technique and tissue-MSI status by polymerase chain reaction (PCR) method will be calculated.\n\nDNA extracted from each tumor tissue will be amplified by standard PCR using six microsatellite loci: NR-21, BA-26, NR-27, BA-25, NR-24, MONO-27. Tumors are designated MSI-H if more than two loci were instable, MSI-L if one locus is instable, and MSS if all loci are stable.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid tumor', 'China', 'MSI', 'ctDNA'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.'}]}, 'descriptionModule': {'briefSummary': 'This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.', 'detailedDescription': 'This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, age≥18 years old.\n2. Confirmed malignant solid tumor by histopathology or cytopathology.\n3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.\n4. Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs\n5. Signed the informed consent with name and time.\n\nExclusion Criteria:\n\n1. Hematological malignancy\n2. Patients who received immuotherapies.\n3. Patients who received blood transfusion within one month before blood collection.\n4. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03596593', 'acronym': 'IMPACT', 'briefTitle': 'Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation', 'orgStudyIdInfo': {'id': 'IMPACT-China'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing.', 'interventionNames': ['Diagnostic Test: SPANOM (identifying MSI status from ctDNA)']}], 'interventions': [{'name': 'SPANOM (identifying MSI status from ctDNA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen Lin, Professor', 'role': 'CONTACT', 'email': 'Linshenpku@163.com', 'phone': '010-88196561'}, {'name': 'Shen Lin, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shen Lin, Professor', 'role': 'CONTACT', 'email': 'Linshenpku@163.com', 'phone': '010-88196561'}, {'name': 'Jian Li, Professor', 'role': 'CONTACT', 'email': 'oncogene@163.com', 'phone': '010-88196561'}], 'overallOfficials': [{'name': 'Shen Lin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}