Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate i… (NCT07575724) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma
China3,300 participantsStarted 2026-05-01
Plain-language summary
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.
Biopsy 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.
The 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
. Candidate for limb-sparing surgery and capable of en-bloc resection;
. Age ≥ 5 years;
. ECOG performance status 0-2;
. Able to understand and sign informed consent.
Exclusion criteria
. Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of local recurrence at 2 years
Timeframe: From the date of surgery to the date of first documented local recurrence, death, or last follow-up, assessed up to 24 months after surgery.
Trial details
NCT IDNCT07575724
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
. Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
. Patients requiring amputation;
. Patients who have received prior treatment for the tumor at non-participating centers;
. Patients with an expected survival of less than 2 years;
. Patients in whom the biopsy tract completely lies within the planned tumor resection field;
. Patients who refuse to provide written informed consent.