PrimaryPhase 2NCT07575724
Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma
A Phase 2 study testing biopsy tract resection and biopsy tract non-resection in people with Primary and Sarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- What is being tested?
- biopsy tract resection and biopsy tract non-resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2026to 1 Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311200
Keyi Wang, MS, 17398046579, wky82630965@gmail.com
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Yefeng Xu, 15068710437, 2173799040@qq.com
About this study
Official title: 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
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.
- Being tested
- biopsy tract resection, biopsy tract non-resection
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy tract resectionProcedure or surgery
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:
Skin 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
All components of the biopsy tract must be removed together with the tumor specimen.
biopsy tract non-resectionProcedure or surgery
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.
If 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.
| Study group | Role | What they receive |
|---|---|---|
| tract resection group | Experimental | Not described Receives: Procedure: biopsy tract resection |
| tract non-section group | Active comparator | Not described Receives: Procedure: biopsy tract non-resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of local recurrence at 2 years
Local recurrence is defined as radiologically or pathologically confirmed recurrence of sarcoma at or adjacent to the primary surgical site after definitive tumor resection. The cumulative incidence of local recurrence will be estimated with death treated as a competing event.
Measured: 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.
Secondary outcomes (14)
Musculoskeletal Tumor Society score
MSTS assesses 6 aspects of a patient's quality including pain, function, emotional, supports, walking and gait with regard to their treatment. higher score. The score ranges from 0% (worst function) to 100% (best function). It is a repeated continuous outcome.
Measured: recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
Henderson failure mode
Henderson failure mode defined as : soft-tissue failure (Type 1), aseptic loosening (Type 2), structural failure (Type 3), infection (Type 4), and tumor progression (Type 5).
Measured: From surgery to 24 months, assessed every 3 months
The Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale (POSAS) questionnare is used to evaluate scar quality from both the patient's and the observer's perspectives. Each scale consists of six items, with each item scored from 1 (normal skin) to 10 (worst imaginable scar). Total scores range from 6 to 60, with lower scores indicating better quality.
Measured: From surgery to 24 months, assessed every 3 months
Soft tissue reconstruction
Soft tissue reconstruction will be recorded as whether the patient required additional soft tissue reconstruction procedures (e.g., skin grafting) during surgery.
Measured: perioperative period
Total surgical duration
The time elapsed from the first incision to the completion of wound closure, measured in minutes.
Measured: During the operative procedure
Biopsy diagnostic accuracy
Diagnostic accuracy was defined as the percentage of participants whose percutaneous biopsy results are concordant with the final histopathological diagnosis from the surgical specimen. This is a binary outcome.
Measured: perioperative period
Metastasis free survival (MFS)
Metastasis-free survival is defined as the time from definitive surgery to the first radiologically confirmed distant metastasis (e.g., lung, bone, or other organs). Metastasis will be assessed using scheduled chest CT scans and other imaging as clinically indicated. Participants without metastasis will be censored at their last follow-up visit.
Measured: From surgery to 24 months, assessed every 6 months
The Toronto Extremity Salvage Score
The Toronto Extremity Salvage Score (TESS) is a patient-reported outcome measure (PROM) specifically designed to evaluate the physical function of individuals who have undergone limb-salvage surgery for bone or soft-tissue sarcomas.The raw score is converted into a percentage ranging from 0 to 100. Higher score indicates better function.
Measured: From surgery to 24 months, assessed every 3 months
Overall survival (OS)
Overall survival is defined as the time from definitive surgery to death from any cause. Participants alive at last follow-up will be censored. Survival status will be assessed at each scheduled visit.
Measured: From surgery to 24 months, assessed every 3 months
Need for re-biopsy
Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.
Measured: preoperative period
Request for external pathology consultation
Number of participants for whom a second opinion from an external pathology department was sought to confirm the primary diagnosis.
Measured: perioperative period
intraoperative blood loss
Total volume of blood lost during the surgical procedure, measured in milliliters (mL).
Measured: During the surgical procedure
length of hospital stay
The total number of days from the date of admission to the date of hospital discharge. This is a continuous outcome
Measured: perioperative period
Major wound complications
Major wound complication was defined according to the O' sullivian et al (the Lancet, 2002). They are defined as a secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts),or wound management without secondary operation.
Wound management included an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer. It will be recorded as binary outcome
Measured: Assessed from the date of surgery to 120 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrimaryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575724
- Sponsor's protocol ID
- LN_Biopsy_2025
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07575724
- Acronym / sponsor ID
- LN_Biopsy_2025
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2033 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tract resection group | Experimental | Procedure: biopsy tract resection |
| tract non-section group | Active comparator | Procedure: biopsy tract non-resection |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy tract resectionSurgeons 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: Skin 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 All components of the biopsy tract must be removed together with the tumor specimen. | Procedure or surgery | tract resection group |
| biopsy tract non-resectionSurgeons 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. If 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. | Procedure or surgery | tract non-section group |
Primary outcome
Cumulative incidence of local recurrence at 2 years
Time frame: 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.
Local recurrence is defined as radiologically or pathologically confirmed recurrence of sarcoma at or adjacent to the primary surgical site after definitive tumor resection. The cumulative incidence of local recurrence will be estimated with death treated as a competing event.
14 secondary outcomes
Musculoskeletal Tumor Society score
Time frame: recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
Henderson failure mode
Time frame: From surgery to 24 months, assessed every 3 months
The Patient and Observer Scar Assessment Scale
Time frame: From surgery to 24 months, assessed every 3 months
Soft tissue reconstruction
Time frame: perioperative period
Total surgical duration
Time frame: During the operative procedure
Biopsy diagnostic accuracy
Time frame: perioperative period
Metastasis free survival (MFS)
Time frame: From surgery to 24 months, assessed every 6 months
The Toronto Extremity Salvage Score
Time frame: From surgery to 24 months, assessed every 3 months
Overall survival (OS)
Time frame: From surgery to 24 months, assessed every 3 months
Need for re-biopsy
Time frame: preoperative period
Request for external pathology consultation
Time frame: perioperative period
intraoperative blood loss
Time frame: During the surgical procedure
length of hospital stay
Time frame: perioperative period
Major wound complications
Time frame: Assessed from the date of surgery to 120 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing biopsy tract resection and biopsy tract non-resection in people with Primary and Sarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nong Lin, MD (13958195545, linnong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of local recurrence at 2 years (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.