Predictive 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/Actively Recruiting
Led by Jinsong Hou · Updated on 2026-04-30
524
Participants Needed
1
Research Sites
56 weeks
Total Duration
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
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
J
Jinsong Hou, PhD
C
Cheng Wang, PhD
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Jinsong Hou
Lead Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Lead Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor