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A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

4. september 2022 opdateret af: Jinsong Hou

A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

524

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510055
        • Rekruttering
        • Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Han race;
  2. Oral squamous cell carcinoma is confirmed by pathology;
  3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
  4. The primary lesion is no more than 4cm;
  5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
  6. Patients and families agree to participate in the study;
  7. Patients do not have cognitive disorders.

Exclusion Criteria:

  1. Do not meet the inclusion criteria;
  2. The primary lesion is more than 4cm or invade adjacent tissues;
  3. Do not review on schedule;
  4. Patients receive not only surgical procedures, but other antineoplastic treatment;
  5. There are serious adverse events after operation;
  6. Patients quit the study voluntarily;
  7. Patients quit the study because of physical condition.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Procedure: Resection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
Eksperimentel: High-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Procedure: Resection for primary lesion only
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
Eksperimentel: Low-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Procedure: Resection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
Eksperimentel: Low-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Procedure: Resection for primary lesion only
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Five-year survival rate
Tidsramme: After the first year, review every three months at a time；The next four years, review every six months at a time.
The time from the first operation to death was recorded
After the first year, review every three months at a time；The next four years, review every six months at a time.
Disease free survival
Tidsramme: After the first year, review every three months at a time；The next four years, review every six months at a time.
The time from the start of surgery to the discovery of the first cervical lymphatic metastases
After the first year, review every three months at a time；The next four years, review every six months at a time.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrence rate
Tidsramme: After the first year, review every three months at a time；The next four years, review every six months at a time.
To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.
After the first year, review every three months at a time；The next four years, review every six months at a time.
Evaluation of quality of life
Tidsramme: After the first year, review every three months at a time；The next four years, review every six months at a time.
Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.
After the first year, review every three months at a time；The next four years, review every six months at a time.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jinsong Hou

Samarbejdspartnere

First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital, Sun Yat-Sen University
Hospital of Stomatology, Sun Yat-Sen University

Efterforskere

  • Studieleder: Jinsong Hou, PhD, Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

4. september 2022

Primær færdiggørelse (Forventet)

30. maj 2025

Studieafslutning (Forventet)

30. juni 2025

Datoer for studieregistrering

Først indsendt

15. april 2016

Først indsendt, der opfyldte QC-kriterier

15. april 2016

Først opslået (Skøn)

19. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HouJ-2015018

Plan for individuelle deltagerdata (IPD)

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