Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-06 @ 6:39 PM
Study NCT ID:
NCT03793205
Status:
UNKNOWN
Last Update Posted:
2019-01-07
First Post:
2019-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of febrile neutropenia', 'timeFrame': 'One year', 'description': 'Incidence of febrile neutropenia in each course'}], 'secondaryOutcomes': [{'measure': 'Incidences of grade 3/4 myelosuppression', 'timeFrame': 'One year', 'description': 'Incidences of grade 3/4 myelosuppression in each course'}, {'measure': 'Times of visits to outpatient and emergency clinics', 'timeFrame': 'One year', 'description': 'Visits to outpatient and emergency clinics in each course'}, {'measure': 'Doses of G-CSF', 'timeFrame': 'One year', 'description': 'Doses of G-CSF administrated in each course'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer', 'Myelosuppression Adult', 'Febrile Neutropenia', 'Chemotherapy-induced Neutropenia']}, 'referencesModule': {'references': [{'pmid': '39696092', 'type': 'DERIVED', 'citation': 'Chen X, Wu M, Ma S, Tan X, Zhong S, Li L. Effects of long-acting versus short-acting granulocyte colony stimulating factor after radiotherapy in gynecologic malignancies: a prospective observational cohort study. BMC Cancer. 2024 Dec 18;24(1):1512. doi: 10.1186/s12885-024-13296-1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed primary gynecologic cancer\n* Good performance status\n* Aged 18 years or older\n* Signed an approved informed consents\n* No immunosuppressive disease\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03793205', 'briefTitle': 'G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'GO-GCSF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-acting G-CSF group', 'description': 'Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.', 'interventionNames': ['Drug: Long-acting G-CSF']}, {'type': 'EXPERIMENTAL', 'label': 'Short-acting G-CSF group', 'description': 'Patients in long-acting G-CSF group only accept short-acting G-CSF.', 'interventionNames': ['Drug: Short-acting G-CSF']}], 'interventions': [{'name': 'Long-acting G-CSF', 'type': 'DRUG', 'description': 'Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.', 'armGroupLabels': ['Long-acting G-CSF group']}, {'name': 'Short-acting G-CSF', 'type': 'DRUG', 'description': 'Short-acting G-CSF will be given as required 24 hours after the chemotherapy.', 'armGroupLabels': ['Short-acting G-CSF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}