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Sarcoma surgery debate: can skipping biopsy track removal reduce harm without raising recurrence risk?

NCT ID NCT07575724

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 4 times

Summary

This study tests whether leaving the needle biopsy track in place during sarcoma surgery is as safe as removing it. The goal is to see if avoiding extra tissue removal can lower complications without increasing the chance of the cancer coming back. About 3,300 people with sarcoma in their arms or legs will take part. The results could change standard surgical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 3,300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma); 2. Candidate for limb-sparing surgery and capable of en-bloc resection; 3. Age ≥ 5 years; 4. ECOG performance status 0-2; 5. Able to understand and sign informed consent. Exclusion Criteria: 1. Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions; 2. Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery; 3. Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis; 4. Patients requiring amputation; 5. Patients who have received prior treatment for the tumor at non-participating centers; 6. Patients with an expected survival of less than 2 years; 7. Patients in whom the biopsy tract completely lies within the planned tumor resection field; 8. Patients who refuse to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary Sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, China

  • the Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311200, China

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