Carcinoma, Squamous CellNCT02743832
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
A study testing Resection for primary lesion and cervical lymph node dissection and Resection for primary lesion only in people with Carcinoma, Squamous Cell, run by Jinsong Hou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Resection for primary lesion and cervical lymph node dissection and Resection for primary lesion only
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Han race;
- Oral squamous cell carcinoma is confirmed by pathology;
- The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
- The primary lesion is no more than 4cm;
- Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
- Patients and families agree to participate in the study;
- Patients do not have cognitive disorders.
Who cannot join
- Do not meet the inclusion criteria;
- The primary lesion is more than 4cm or invade adjacent tissues;
- Do not review on schedule;
- Patients receive not only surgical procedures, but other antineoplastic treatment;
- There are serious adverse events after operation;
- Patients quit the study voluntarily;
- Patients quit the study because of physical condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
Guangzhou, Guangdong, 510055
Jinsong Hou, PhD, 86-13825141651, houjsgz@aliyun.com
Cheng Wang, PhD, 86-13760853366, drwangcheng@outlook.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Resection for primary lesion and cervical lymph node dissection, Resection for primary lesion only
- Keywords
- Oral squamous cell carcinoma, Tumor budding, Cervical lymph node dissection
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection for primary lesion and cervical lymph node dissectionProcedure or surgery
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
Resection for primary lesion onlyProcedure or surgery
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| High-level tumor budding group with CLND | Experimental | 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. Receives: Procedure: Resection for primary lesion and cervical lymph node dissection |
| High-level tumor budding group without CLND | Experimental | Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level. Receives: Procedure: Resection for primary lesion only |
| Low-level tumor budding group with CLND | Experimental | 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. Receives: Procedure: Resection for primary lesion and cervical lymph node dissection |
| Low-level tumor budding group without CLND | Experimental | Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level. Receives: Procedure: Resection for primary lesion only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year survival rate
The time from the first operation to death was recorded
Measured: 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
The time from the start of surgery to the discovery of the first cervical lymphatic metastases
Measured: After the first year, review every three months at a time；The next four years, review every six months at a time.
Secondary outcomes (2)
Recurrence rate
To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.
Measured: 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
Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.
Measured: After the first year, review every three months at a time；The next four years, review every six months at a time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start4 May 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinsong Hou
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, Hospital of Stomatology, Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Jinsong Hou, Sun Yat-sen University
- Investigators
- Jinsong Hou, PhD, Study director, Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743832
- Sponsor's protocol ID
- HouJ-2015018
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2016
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almangush A, Salo T, Hagstrom J, Leivo I. Tumour budding in head and neck squamous cell carcinoma - a systematic review. Histopathology. 2014 Nov;65(5):587-94. doi: 10.1111/his.12471. Epub 2014 Oct 6.
PubMed 24897954Almangush A, Bello IO, Keski-Santti H, Makinen LK, Kauppila JH, Pukkila M, Hagstrom J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grenman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer. Head Neck. 2014 Jun;36(6):811-8. doi: 10.1002/hed.23380. Epub 2013 Sep 2.
PubMed 23696499Da Sacco L, Masotti A. Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region. Int J Mol Sci. 2012 Dec 27;14(1):480-95. doi: 10.3390/ijms14010480.
PubMed 23271365Xie N, Wang C, Liu X, Li R, Hou J, Chen X, Huang H. Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma. J Oral Pathol Med. 2015 Apr;44(4):266-72. doi: 10.1111/jop.12242. Epub 2014 Aug 28.
PubMed 25169851Hori Y, Kubota A, Yokose T, Furukawa M, Matsushita T, Takita M, Mitsunaga S, Mizoguchi N, Nonaka T, Nakayama Y, Oridate N. Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma. Head Neck Pathol. 2017 Dec;11(4):477-486. doi: 10.1007/s12105-017-0814-1. Epub 2017 Apr 3.
PubMed 28374102
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT02743832
- Acronym / sponsor ID
- HouJ-2015018
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Oral squamous cell carcinoma, Tumor budding, Cervical lymph node dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Jinsong HouUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, Hospital of Stomatology, Sun Yat-Sen University
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-level tumor budding group with CLND | Experimental | Procedure: Resection for primary lesion and cervical lymph node dissectionResection 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. |
| High-level tumor budding group without CLND | Experimental | Procedure: Resection for primary lesion onlyOnly resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level. |
| Low-level tumor budding group with CLND | Experimental | Procedure: Resection for primary lesion and cervical lymph node dissectionResection 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. |
| Low-level tumor budding group without CLND | Experimental | Procedure: Resection for primary lesion onlyOnly resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Han race;
- Oral squamous cell carcinoma is confirmed by pathology;
- The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
- The primary lesion is no more than 4cm;
- Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
Key exclusion criteria (7 listed)
- Do not meet the inclusion criteria;
- The primary lesion is more than 4cm or invade adjacent tissues;
- Do not review on schedule;
- Patients receive not only surgical procedures, but other antineoplastic treatment;
- There are serious adverse events after operation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection for primary lesion and cervical lymph node dissectionResection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma. | Procedure or surgery | High-level tumor budding group with CLND, Low-level tumor budding group with CLND |
| Resection for primary lesion onlyOnly resection for primary lesion is performed in the early-stage oral squamous cell carcinoma. | Procedure or surgery | High-level tumor budding group without CLND, Low-level tumor budding group without CLND |
Primary outcome
Five-year survival rate
Time frame: 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
Disease free survival
Time frame: 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
2 secondary outcomes
Recurrence rate
Time frame: 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
Time frame: After the first year, review every three months at a time；The next four years, review every six months at a time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 24897954Almangush A, Salo T, Hagstrom J, Leivo I. Tumour budding in head and neck squamous cell carcinoma - a systematic review. Histopathology. 2014 Nov;65(5):587-94. doi: 10.1111/his.12471. Epub 2014 Oct 6.
- Results publication: PubMed 23696499Almangush A, Bello IO, Keski-Santti H, Makinen LK, Kauppila JH, Pukkila M, Hagstrom J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grenman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer. Head Neck. 2014 Jun;36(6):811-8. doi: 10.1002/hed.23380. Epub 2013 Sep 2.
- Results publication: PubMed 23271365Da Sacco L, Masotti A. Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region. Int J Mol Sci. 2012 Dec 27;14(1):480-95. doi: 10.3390/ijms14010480.
- Results publication: PubMed 25169851Xie N, Wang C, Liu X, Li R, Hou J, Chen X, Huang H. Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma. J Oral Pathol Med. 2015 Apr;44(4):266-72. doi: 10.1111/jop.12242. Epub 2014 Aug 28.
- Results publication: PubMed 28374102Hori Y, Kubota A, Yokose T, Furukawa M, Matsushita T, Takita M, Mitsunaga S, Mizoguchi N, Nonaka T, Nakayama Y, Oridate N. Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma. Head Neck Pathol. 2017 Dec;11(4):477-486. doi: 10.1007/s12105-017-0814-1. Epub 2017 Apr 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinsong Hou, PhD study director
Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection for primary lesion and cervical lymph node dissection and Resection for primary lesion only in people with Carcinoma, Squamous Cell, run by Jinsong Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Hou, PhD (86-13825141651, houjsgz@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year survival rate (time frame: After the first year, review every three months at a time；The next four years, review every six months at a time.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743832, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.