Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-05-29 @ 12:22 PM
Study NCT ID:
NCT03549195
Status:
UNKNOWN
Last Update Posted:
2018-06-07
First Post:
2018-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of micro-metastasis sentinel lymph node', 'timeFrame': '7 days', 'description': 'Detection of micro-metastasis sentinel lymph node per patient'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '7 days', 'description': 'Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP'}, {'measure': 'Specificity', 'timeFrame': '7 days', 'description': 'Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP'}, {'measure': 'Incidence of adverse events', 'timeFrame': '7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Sentinel Lymph Node']}, 'descriptionModule': {'briefSummary': "Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Without childbearing requirements at the time of consent.\n* FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.\n* Subject has provided written informed consent.\n\nExclusion Criteria:\n\n* Breast-feeding or pregnant.\n* Ongoing participation in another clinical trial with an investigational drug with 3 months\n* Own allergy towards ICG and/or alcohol\n* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases\n* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency'}, 'identificationModule': {'nctId': 'NCT03549195', 'briefTitle': 'TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients', 'orgStudyIdInfo': {'id': 'TMTP1-ICG-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ICG', 'interventionNames': ['Procedure: ICG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ICG-CP', 'description': 'CP, control peptide', 'interventionNames': ['Procedure: ICG-CP']}, {'type': 'EXPERIMENTAL', 'label': 'ICG-TMTP1', 'description': 'also named as TMTP1-ICG', 'interventionNames': ['Procedure: ICG-TMTP1']}], 'interventions': [{'name': 'ICG', 'type': 'PROCEDURE', 'description': "The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.", 'armGroupLabels': ['ICG']}, {'name': 'ICG-CP', 'type': 'PROCEDURE', 'description': "The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.", 'armGroupLabels': ['ICG-CP']}, {'name': 'ICG-TMTP1', 'type': 'PROCEDURE', 'description': "The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.", 'armGroupLabels': ['ICG-TMTP1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Danhui Weng, MD', 'role': 'CONTACT', 'email': 'weng.dh@gmail.com', 'phone': '02783663351', 'phoneExt': '02783663351'}], 'facility': 'Tongji Hospital, Tongji Medical College, HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Danhui H Weng, MD', 'role': 'CONTACT', 'email': 'weng.dh@gmail.com', 'phone': '02783663351'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ding Ma', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}