Tumour budding in head and neck squamous cell carcinoma - a systematic review.
Alhadi Almangush, Tuula Salo, Jaana Hagström...
https://pubmed.ncbi.nlm.nih.gov/24897954Actively Recruiting
Phase Not Applicable
Age: 20Years - 70Years
All Genders
ID02743832
A Randomized, Multicenter, Prospective, Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma
Led by Jinsong Hou · Updated on 2026-04-30
524
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
J
Jinsong Hou
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Oral squamous cell carcinoma is a common cancer in the mouth and face area that often spreads early to nearby lymph nodes. This research investigates if removing cervical lymph nodes is always necessary for early-stage cases or if it could sometimes be avoided. The study explores whether tumor budding can help guide personalized surgery plans to avoid unnecessary lymph node removal. Participants will be divided based on tumor budding levels into four groups. Some will have both the primary tumor removed and cervical lymph node dissection, while others will have only the primary tumor removed. This approach tests if tumor budding levels can help decide the best surgical treatment for early-stage oral squamous cell carcinoma. Participants will be followed for five years with regular check-ups every three months during the first year and every six months afterward. Researchers will assess survival rates, disease-free survival, recurrence rates, and quality of life. The study includes physical exams and MRI scans to monitor for cancer spread and overall health throughout the follow-up period.
CONDITIONS
Brief Title
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Who Can Participate
Age: 20Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Han race
- Oral squamous cell carcinoma confirmed by pathology
- Tumor located in the primary two-thirds of the tongue, buccal mucosa, gingiva, mouth floor, or hard palate mucosa
- Primary tumor size no more than 4 cm
- No cervical lymph node or distant metastases found in clinical and MRI examinations
- Patients and families agree to participate
- Patients have no cognitive disorders
You will not qualify if you...
- Does not meet inclusion criteria
- Primary tumor larger than 4 cm or invading adjacent tissues
- Failure to attend scheduled reviews
- Received treatments other than surgical procedures
- Serious adverse events after surgery
- Voluntary withdrawal from the study
- Withdrawal due to physical condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo resection of the primary tumor with or without cervical lymph node dissection based on tumor budding levels.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 5 years
Participants are followed to monitor survival, disease recurrence, and quality of life after surgery.
Reviews every 3 months for the first year; then every 6 months for the next 4 years
Trial Site Locations
Total: 1 location
1
Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
Guangzhou, Guangdong, China, 510055
Actively Recruiting
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Research Team
J
Jinsong Hou, PhD
C
Cheng Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer.
Alhadi Almangush, Ibrahim O Bello, Harri Keski-Säntti...
https://pubmed.ncbi.nlm.nih.gov/23696499Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region.
Letizia Da Sacco, Andrea Masotti
https://pubmed.ncbi.nlm.nih.gov/23271365Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma.
Nan Xie, Cheng Wang, Xiqiang Liu...
https://pubmed.ncbi.nlm.nih.gov/25169851Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma.
Yukiko Hori, Akira Kubota, Tomoyuki Yokose...
https://pubmed.ncbi.nlm.nih.gov/28374102