Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT05242861
Status:
RECRUITING
Last Update Posted:
2022-02-16
First Post:
2022-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2022-02-06', 'studyFirstSubmitQcDate': '2022-02-06', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': '5-year', 'description': 'the percentage of participants in the group who survives'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival rate', 'timeFrame': '5-year', 'description': 'the percentage of participants in the group whose disease is likely to remain stable'}, {'measure': 'Side effects', 'timeFrame': '5-year', 'description': 'side effects associated with treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachytherapy', 'Cervical Cancer', 'Endometrial Cancer', 'Vaginal Cancer', 'Vulvar Cancer', 'Image Guided', '3D Print'], 'conditions': ['Brachytherapy', 'Uterine Cervical Neoplasms', 'Uterine Neoplasms', 'Vulvar Cancer', 'Vaginal Cancer', 'Ovarian Neoplasms', 'Gynecologic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '27134181', 'type': 'BACKGROUND', 'citation': 'Sturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29.'}, {'pmid': '26743833', 'type': 'BACKGROUND', 'citation': 'Lindegaard JC, Madsen ML, Traberg A, Meisner B, Nielsen SK, Tanderup K, Spejlborg H, Fokdal LU, Norrevang O. Individualised 3D printed vaginal template for MRI guided brachytherapy in locally advanced cervical cancer. Radiother Oncol. 2016 Jan;118(1):173-5. doi: 10.1016/j.radonc.2015.12.012. Epub 2015 Dec 29.'}, {'pmid': '30479625', 'type': 'BACKGROUND', 'citation': 'Sekii S, Tsujino K, Kosaka K, Yamaguchi S, Kubota H, Matsumoto Y, Ota Y, Sasaki R, Soejima T. Inversely designed, 3D-printed personalized template-guided interstitial brachytherapy for vaginal tumors. J Contemp Brachytherapy. 2018 Oct;10(5):470-477. doi: 10.5114/jcb.2018.78832. Epub 2018 Oct 9.'}, {'pmid': '26108891', 'type': 'BACKGROUND', 'citation': 'Harris BD, Nilsson S, Poole CM. A feasibility study for using ABS plastic and a low-cost 3D printer for patient-specific brachytherapy mould design. Australas Phys Eng Sci Med. 2015 Sep;38(3):399-412. doi: 10.1007/s13246-015-0356-3. Epub 2015 Jun 25.'}, {'pmid': '23849695', 'type': 'RESULT', 'citation': 'Han K, Milosevic M, Fyles A, Pintilie M, Viswanathan AN. Trends in the utilization of brachytherapy in cervical cancer in the United States. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):111-9. doi: 10.1016/j.ijrobp.2013.05.033. Epub 2013 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'Brachytherapy for gynecological cancers will be studied retrospectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 80 female\n* Underwent brachytherapy\n* With gynecological cancer\n\nExclusion Criteria:\n\n* Refusal to enter this trial'}, 'identificationModule': {'nctId': 'NCT05242861', 'acronym': 'RetroBT', 'briefTitle': 'Retrospective Study of Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'A Retrospective Study of Brachytherapy in Gynecological Cancers', 'orgStudyIdInfo': {'id': 'BTOG 2201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cervix radical BT', 'interventionNames': ['Radiation: Brachytherapy']}, {'label': 'Cervix adjuvant BT', 'interventionNames': ['Radiation: Brachytherapy']}, {'label': 'Cervix palliative BT', 'interventionNames': ['Radiation: Brachytherapy']}, {'label': 'Uterus BT', 'interventionNames': ['Radiation: Brachytherapy']}, {'label': 'Other GO cancer BT', 'interventionNames': ['Radiation: Brachytherapy']}], 'interventions': [{'name': 'Brachytherapy', 'type': 'RADIATION', 'description': 'Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy', 'armGroupLabels': ['Cervix adjuvant BT', 'Cervix palliative BT', 'Cervix radical BT', 'Other GO cancer BT', 'Uterus BT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Zhang', 'role': 'CONTACT', 'email': 'zhangxiang@zjcc.org.cn', 'phone': '0086-571-88122048'}, {'name': 'Xiang Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianhong Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yeqiang Tu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}