[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638050":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tract resection group","EXPERIMENTAL",null,[13],"Procedure: biopsy tract resection",{"label":15,"type":16,"description":11,"interventionNames":17},"tract non-section group","ACTIVE_COMPARATOR",[18],"Procedure: biopsy tract non-resection",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","biopsy tract resection","Surgeons will perform standard en-bloc tumor resection according to oncologic principles. In the biopsy tract resection group, complete biopsy tract excision is defined as en-bloc removal of the entire needle biopsy pathway, including:\n\nSkin entry site: the original puncture site on the skin surface Subcutaneous and soft tissue tract: all intervening tissues traversed by the biopsy needle Deep tract structures: any muscle, fascia, periosteum, or bone structures penetrated by the needle Intratumoral component: the terminal segment of the needle pathway within the tumor\n\nAll components of the biopsy tract must be removed together with the tumor specimen.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"biopsy tract non-resection","Surgeons will perform standard en bloc tumor resection in accordance with oncologic principles. In the non-resection group, the needle biopsy tract will not be intentionally excised. The biopsy tract, including the skin entry site and intervening soft tissue pathway, will be preserved unless it lies within the planned tumor resection field.\n\nIf any portion of the biopsy tract is located within the standard oncologic resection field required to achieve negative margins, it will be removed as part of the tumor specimen; however, no additional resection will be performed specifically to excise the biopsy tract.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Nong Lin, MD","CONTACT","13958195545","linnong@zju.edu.cn",[36],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"the Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","311200","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.16142,30.29365,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":11,"email":53},"Keyi Wang, MS","17398046579","wky82630965@gmail.com",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100638050","phase-2-comparison-of-the-effects-of-needle-biopsy-tract-resection-and-non-resection-on-recurrence-rate-in-patients-with-primary-extremity-sarcoma-100638050",false,"NCT07575724","Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma","Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma: Study Protocol of a Randomized, Non-inferior Clinical Trial","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);\n2. Candidate for limb-sparing surgery and capable of en-bloc resection;\n3. Age ≥ 5 years;\n4. ECOG performance status 0-2;\n5. Able to understand and sign informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;\n2. Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;\n3. Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;\n4. Patients requiring amputation;\n5. Patients who have received prior treatment for the tumor at non-participating centers;\n6. Patients with an expected survival of less than 2 years;\n7. Patients in whom the biopsy tract completely lies within the planned tumor resection field;\n8. Patients who refuse to provide written informed consent.","ALL","5 Years",{"count":66,"type":67},3300,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This randomized, non-inferiority clinical trial aims to evaluate whether non-resection of needle biopsy tract is non-inferior to routine biopsy tract resection in terms of local recurrence in patients with primary extremity musculoskeletal sarcoma undergoing en-bloc surgical treatment.\n\nBiopsy tract resection is traditionally recommended to reduce the risk of tumor seeding; however, its benefit in reducing recurrence has not been definitively demonstrated, particularly when core needle biopsy is widely used. Also, avoiding biopsy tract resection may preserve uninvolved tissue without compromising oncologic safety.\n\nThe primary objective of this study is to compare local recurrence rates between patients who undergo biopsy tract resection and those who do not. Secondary objectives include comparisons of surgical complications, functional outcomes, overall survival, and progression-free survival.",[73,74],"Primary","Sarcoma","NOT_YET_RECRUITING","2026-05-04",{"date":78,"type":79},"2026-05-08","ACTUAL",{"date":81,"type":67},"2026-05-01",{"date":83,"type":67},"2033-12-01",{"name":5,"class":6},1]