Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 4:08 AM
Study NCT ID:
NCT05707767
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2022-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Surgical Treatment Strategies for Chordoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002817', 'term': 'Chordoma'}], 'ancestors': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2022-10-09', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excision Extension', 'timeFrame': '1 week after surgery.', 'description': 'Clinical and radiographic assessments of excision extension of tumor.'}], 'secondaryOutcomes': [{'measure': 'OS (Overall Survival)', 'timeFrame': '2 years', 'description': 'Overall Survival of patient underwent surgery.'}, {'measure': 'PFS (Progression-Free Survival)', 'timeFrame': '2 years', 'description': 'Progression-Free Survival of patient underwent surgery.'}, {'measure': 'DFS (Disease Free Survival)', 'timeFrame': '2 years', 'description': 'Disease Free Survival of patient underwent surgery.'}, {'measure': 'ORR (Objective Response Rate)', 'timeFrame': '2 years', 'description': 'Objective Response Rate of patient underwent surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chordoma'], 'conditions': ['Chordoma of Spine', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '22300861', 'type': 'RESULT', 'citation': 'Walcott BP, Nahed BV, Mohyeldin A, Coumans JV, Kahle KT, Ferreira MJ. Chordoma: current concepts, management, and future directions. Lancet Oncol. 2012 Feb;13(2):e69-76. doi: 10.1016/S1470-2045(11)70337-0.'}, {'pmid': '34266694', 'type': 'RESULT', 'citation': 'Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.'}, {'pmid': '31243811', 'type': 'RESULT', 'citation': 'Yeter HG, Kosemehmetoglu K, Soylemezoglu F. Poorly differentiated chordoma: review of 53 cases. APMIS. 2019 Sep;127(9):607-615. doi: 10.1111/apm.12978.'}, {'pmid': '33567141', 'type': 'RESULT', 'citation': 'Kolz JM, Wellings EP, Houdek MT, Clarke MJ, Yaszemski MJ, Rose PS. Surgical treatment of primary mobile spine chordoma. J Surg Oncol. 2021 Apr;123(5):1284-1291. doi: 10.1002/jso.26423. Epub 2021 Feb 10.'}, {'pmid': '23744869', 'type': 'RESULT', 'citation': 'Williams BJ, Raper DM, Godbout E, Bourne TD, Prevedello DM, Kassam AB, Park DM. Diagnosis and treatment of chordoma. J Natl Compr Canc Netw. 2013 Jun 1;11(6):726-31. doi: 10.6004/jnccn.2013.0089.'}]}, 'descriptionModule': {'briefSummary': 'Chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. Total resection is challenging in mobile spine because of the complex anatomy and bone invasion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 70 ys,\n* With a diagnosis of chordoma confirmed by pathology,\n* Undergone surgical treatment in our hospital,\n* Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.\n\nExclusion Criteria:\n\n* Suffer from other tumors,\n* Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.'}, 'identificationModule': {'nctId': 'NCT05707767', 'briefTitle': 'A Prospective Study of Surgical Treatment Strategies for Chordoma', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'A Prospective Study of Surgical Treatment Strategies for Chordoma', 'orgStudyIdInfo': {'id': 'XW-NS-CHORC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chordoma Patients', 'description': 'Chordoma Patients', 'interventionNames': ['Procedure: Resection surgery']}], 'interventions': [{'name': 'Resection surgery', 'type': 'PROCEDURE', 'description': 'Patients undergo resection surgery in our hospital.', 'armGroupLabels': ['Chordoma Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zan Chen, MD. PHD.', 'role': 'CONTACT', 'email': 'chenzan66@163.com', 'phone': '18131166269'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}