Oral Cancerspeech omicsNCT07347899
Speech-based AI-driven Diagnostics and Rehabilitation for Oral and Oropharyngeal Cancer.
An observational study of Oral Cancer and Oropharyngeal Cancer, run by Yudong Xiao at 1 site in China.
Trial summary
Participants diagnosed with oral cancer, oropharyngeal cancer, or oral potentially malignant lesions, as well as healthy controls, had their speech audio recordings collected for the development and validation of AI-driven models for diagnosis and prognosis prediction of oral cancer and oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Oropharyngeal Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 501 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2017to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In-patient participants diagnosed with oral cancer, oropharyngeal cancer or oral potentially malignant lesion and healthy volunteers.
Who may be able to join
- diagnosed as having OC or OPC regardless of concrete pathological subtype (e.g., epithelial, adenoid, odontogenic)
- without a history of other tumor-related treatment before the initial evaluation, such as radiotherapy and chemotherapy
- native Chinese speakers
Who cannot join
- hearing impairment
- history of stuttering, cerebrovascular accident, brain trauma, neurodegenerative diseases
- severe dental or maxillofacial deformity
- cleft lip, cleft palate, and related post-treatment status
- severe cardiology conditions, breathing/pulmonology disorders, psychiatric disorders or other illnesses preventing patients from receiving standard surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Department of oral and maxillofacial surgery, Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, 510055
About this study
Official title: A Preliminary Study on the Phonetics of Resonance and Articulation Disorders Caused by Defects of the Oral and Maxillofacial Speech Organs and Speech Therapy
Participants diagnosed with oral cancer, oropharyngeal cancer, or oral potentially malignant lesions, as well as healthy controls, had their speech audio recordings collected for the development and validation of AI-driven models for diagnosis and prognosis prediction of oral cancer and oropharyngeal cancer.
Read the detailed description
Participants were instructed to articulate three sustained vowels (/a/, /i/, /u/) repeatedly at a moderate volume and pace, with three repetitions per vowel and each utterance lasting at least one second. We developed a neuromorphic computing framework that orthogonally decomposes acoustic features into ultra-dimensional omics representations, enabling the characterization of both localized lesions and systemic physiological conditions. The study collected a comprehensive spectrum of biological profiles, including sociodemographic characteristics, tumor metrics, oral function-related factors, patient-reported outcome measures (PROMs), immunoinflammatory indices, and general health status indicators, to thoroughly investigate the paralinguistic representations of transformed speech omics features. These features were then rigorously evaluated for their clinical efficacy across multiple diagnostic tasks, including screening, early detection, pathological diagnosis, disease staging, and risk factor identification.
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Keywords
- speech signal analysis, diagnostic models, vowel acoustics, bio-inspired computing
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy control and oral potentially malignant lesion | Speakers with oral potentially malignant lesions or healthy status | |
| oral cancer and oropharyngeal cancer | Patients diagnosed with oral cancer or oropharyngeal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC value
Area under the receiver operating characteristic curve (AUC) for discriminating OC/OPC from healthy controls
Measured: From enrollment to the report of surgical pathology，up to two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start17 Jul 2017
- Primary completion30 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 501 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yudong Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yudong Xiao, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347899
- Sponsor's protocol ID
- ERC-[2014]-35
- Acronym
- speech omics
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw audio files and corresponding metadata files for this study are uploaded and shared. The underlying code for this study, including PRAAT scripts for speech preprocessing and automatic feature extraction, and python codes for speech omics representation, can be accessed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Phonetics of Resonance and Articulation Disorders Caused by Defects of the Oral and Maxillofacial Speech Organs and Speech Therapy
- ClinicalTrials.gov ID
- NCT07347899
- Acronym / sponsor ID
- speech omics / ERC-[2014]-35
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Keywords
- speech signal analysis, diagnostic models, vowel acoustics, bio-inspired computing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Yudong XiaoUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Jan 2026 (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.
Participants diagnosed with oral cancer, oropharyngeal cancer, or oral potentially malignant lesions, as well as healthy controls, had their speech audio recordings collected for the development and validation of AI-driven models for diagnosis and prognosis prediction of oral cancer and oropharyngeal cancer.
Detailed description
Participants were instructed to articulate three sustained vowels (/a/, /i/, /u/) repeatedly at a moderate volume and pace, with three repetitions per vowel and each utterance lasting at least one second. We developed a neuromorphic computing framework that orthogonally decomposes acoustic features into ultra-dimensional omics representations, enabling the characterization of both localized lesions and systemic physiological conditions. The study collected a comprehensive spectrum of biological profiles, including sociodemographic characteristics, tumor metrics, oral function-related factors, patient-reported outcome measures (PROMs), immunoinflammatory indices, and general health status indicators, to thoroughly investigate the paralinguistic representations of transformed speech omics features. These features were then rigorously evaluated for their clinical efficacy across multiple diagnostic tasks, including screening, early detection, pathological diagnosis, disease staging, and risk factor identification.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control and oral potentially malignant lesion | – | –Speakers with oral potentially malignant lesions or healthy status |
| oral cancer and oropharyngeal cancer | – | –Patients diagnosed with oral cancer or oropharyngeal cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In-patient participants diagnosed with oral cancer, oropharyngeal cancer or oral potentially malignant lesion and healthy volunteers.
Key inclusion criteria (3 listed)
- diagnosed as having OC or OPC regardless of concrete pathological subtype (e.g., epithelial, adenoid, odontogenic)
- without a history of other tumor-related treatment before the initial evaluation, such as radiotherapy and chemotherapy
- native Chinese speakers
Key exclusion criteria (5 listed)
- hearing impairment
- history of stuttering, cerebrovascular accident, brain trauma, neurodegenerative diseases
- severe dental or maxillofacial deformity
- cleft lip, cleft palate, and related post-treatment status
- severe cardiology conditions, breathing/pulmonology disorders, psychiatric disorders or other illnesses preventing patients from receiving standard surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUC value
Time frame: From enrollment to the report of surgical pathology，up to two weeks.
Area under the receiver operating characteristic curve (AUC) for discriminating OC/OPC from healthy controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Raw audio files and corresponding metadata files for this study are uploaded and shared. The underlying code for this study, including PRAAT scripts for speech preprocessing and automatic feature extraction, and python codes for speech omics representation, can be accessed.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Oropharyngeal Cancer, run by Yudong Xiao 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value (time frame: From enrollment to the report of surgical pathology，up to two weeks.). 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 16 Jan 2026.