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New study aims to spare oral cancer patients from unnecessary neck surgery

NCT ID NCT02743832

Knowledge-focused Sponsor: Jinsong Hou Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a feature called tumor budding can help doctors decide if early-stage oral cancer patients need neck lymph node removal. About 524 participants will be randomly assigned to either have the main tumor removed alone or also have neck dissection. The goal is to see if skipping neck dissection is safe and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors decide which early-stage oral cancer patients need neck surgery, reducing unnecessary procedures.
What could go wrong
This is an observational study without a new drug or treatment, so it won't directly cure or control the disease. Results may not change standard care immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 524 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

oral cavity squamous cell carcinoma squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, squamous cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510055, China

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