Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma

4 maja 2026 zaktualizowane przez: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

3300

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 311200
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: tract resection group
Procedura: 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:

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.
Aktywny komparator: tract non-section group
Procedura: 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.

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cumulative incidence of local recurrence at 2 years
Ramy czasowe: 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.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Musculoskeletal Tumor Society score
Ramy czasowe: recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
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.
recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
Henderson failure mode
Ramy czasowe: From surgery to 24 months, assessed every 3 months
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).
From surgery to 24 months, assessed every 3 months
The Patient and Observer Scar Assessment Scale
Ramy czasowe: From surgery to 24 months, assessed every 3 months
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.
From surgery to 24 months, assessed every 3 months
Soft tissue reconstruction
Ramy czasowe: perioperative period
Soft tissue reconstruction will be recorded as whether the patient required additional soft tissue reconstruction procedures (e.g., skin grafting) during surgery.
perioperative period
Total surgical duration
Ramy czasowe: During the operative procedure
The time elapsed from the first incision to the completion of wound closure, measured in minutes.
During the operative procedure
Biopsy diagnostic accuracy
Ramy czasowe: perioperative period
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.
perioperative period
Metastasis free survival (MFS)
Ramy czasowe: From surgery to 24 months, assessed every 6 months
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.
From surgery to 24 months, assessed every 6 months
The Toronto Extremity Salvage Score
Ramy czasowe: From surgery to 24 months, assessed every 3 months
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.
From surgery to 24 months, assessed every 3 months
Overall survival (OS)
Ramy czasowe: From surgery to 24 months, assessed every 3 months
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.
From surgery to 24 months, assessed every 3 months
Need for re-biopsy
Ramy czasowe: preoperative period
Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.
preoperative period
Request for external pathology consultation
Ramy czasowe: perioperative period
Number of participants for whom a second opinion from an external pathology department was sought to confirm the primary diagnosis.
perioperative period
intraoperative blood loss
Ramy czasowe: During the surgical procedure
Total volume of blood lost during the surgical procedure, measured in milliliters (mL).
During the surgical procedure
length of hospital stay
Ramy czasowe: perioperative period
The total number of days from the date of admission to the date of hospital discharge. This is a continuous outcome
perioperative period
Major wound complications
Ramy czasowe: Assessed from the date of surgery to 120 days after surgery.

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
Assessed from the date of surgery to 120 days after surgery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2031

Ukończenie studiów (Szacowany)

1 grudnia 2033

Daty rejestracji na studia

Pierwszy przesłany

2 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 maja 2026

Pierwszy wysłany (Rzeczywisty)

8 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 maja 2026

Ostatnia weryfikacja

1 listopada 2025

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LN_Biopsy_2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Mięsak

Badania kliniczne na biopsy tract resection

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Finland

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj