Neck DislocationNCT03385720
Submandibular Gland Preservation in Neck Dissection
A study testing modified neck dissection and traditional neck dissection in people with Neck Dislocation and Oral Cancer, run by Guang-Yan Yu at 1 site in China.
Trial summary
Trial design: a randomized controlled trial. Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Neck Dislocation, Oral Cancer
- What is being tested?
- modified neck dissection and traditional neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2017to Dec 2030
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Who cannot join
- Cancer of the floor of the mouth.
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
Peking University School of Stomatology
Beijing, Beijing Municipality, 100081
Guang-Yan Yu, Professor, 86 10 13426227717, gyyu@263.net
About this study
Official title: Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma
Trial design: a randomized controlled trial.
Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.
Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.
Primary Parameters: survival rate, mortality rate
- Conditions
- Neck Dislocation, Oral Cancer
- Being tested
- modified neck dissection, traditional neck dissection
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified neck dissectionProcedure or surgery
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
traditional neck dissectionProcedure or surgery
traditional neck dissection without preservation of submandibular gland
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Procedure: modified neck dissection |
| Control group | Active comparator | Not described Receives: Procedure: traditional neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival rate
disease free survival rate
Measured: 5-year after operation
3-year survival rate
disease free survival rate
Measured: 3-year after operation
5-year regional recurrence rate
rate of participants with tumor recurrence in the neck
Measured: 5-year after operation
3-year regional recurrence rate
rate of participants with tumor recurrence in the neck
Measured: 3-year after operation
1-year regional recurrence rate
rate of participants with tumor recurrence in the neck
Measured: 1-year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start5 Dec 2017
- Primary completionDec 2023 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck DislocationStudies 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
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang-Yan Yu
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Peking University School of Stomatology
- Responsible party
- Sponsor-investigator, Guang-Yan Yu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385720
- Sponsor's protocol ID
- sujiazeng
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03385720
- Acronym / sponsor ID
- sujiazeng
- Conditions
- Neck Dislocation, Oral Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guang-Yan YuUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Peking University School of Stomatology
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Dec 2017 (actual)
- 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.
Trial design: a randomized controlled trial.
Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.
Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.
Primary Parameters: survival rate, mortality rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: modified neck dissection |
| Control group | Active comparator | Procedure: traditional neck dissection |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Key exclusion criteria (1 listed)
- Cancer of the floor of the mouth.
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 |
|---|---|---|
| modified neck dissectionModified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection. | Procedure or surgery | Experimental group |
| traditional neck dissectiontraditional neck dissection without preservation of submandibular gland | Procedure or surgery | Control group |
Primary outcome
5-year survival rate
Time frame: 5-year after operation
disease free survival rate
3-year survival rate
Time frame: 3-year after operation
disease free survival rate
5-year regional recurrence rate
Time frame: 5-year after operation
rate of participants with tumor recurrence in the neck
3-year regional recurrence rate
Time frame: 3-year after operation
rate of participants with tumor recurrence in the neck
1-year regional recurrence rate
Time frame: 1-year after operation
rate of participants with tumor recurrence in the neck
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 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified neck dissection and traditional neck dissection in people with Neck Dislocation and Oral Cancer, run by Guang-Yan Yu 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 1 inclusion and 1 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 Mar 2023. 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 Jia-Zeng Su, Dr. (86 10 82195992, sujiazeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year survival rate (time frame: 5-year after operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.