Hypopharyngeal CancerML-HNC-RiskNCT07532538
A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions
An observational study of Hypopharyngeal Cancer and Laryngeal Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study aims to develop and validate a clinical prediction model for the risk of head and neck cancerous lesions using deep learning combined with AI algorithms, based on multi-center clinical data. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypopharyngeal Cancer, Laryngeal Cancer, Head and Neck Cancer
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Nov 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study cohort comprised outpatients and inpatients from the otolaryngology departments of the participating medical centers, who underwent laryngoscopy primarily for initial presenting symptoms such as pharyngeal discomfort and hoarseness.
Who may be able to join
- Age ≥ 18 years old. Patients with complete clinical data information and laryngoscopic images.
Who cannot join
- Refusal to sign the informed consent form. Incomplete clinical data. Known diagnosis of other head and neck malignancies (thyroid cancer, malignant parotid tumors, etc.
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
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Junyi Wang, +86 13309609232, songjiu3411@outlook.com
About this study
Official title: A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions: A Multidimensional Feature Study Integrating Demographics and Clinical Symptomatology
This study aims to develop and validate a clinical prediction model for the risk of head and neck cancerous lesions using deep learning combined with AI algorithms, based on multi-center clinical data.
Read the detailed description
Vocal health has emerged as a prominent public health challenge. Phonation relies on precise neuromuscular and respiratory coordination, a physiological process frequently compromised by systemic senescence, multimorbidity, and neuromuscular degeneration. This complex pathophysiological interplay makes it exceedingly difficult to clinically distinguish early-stage laryngeal malignancies from common benign voice disorders (e.g., vocal fold cysts, vocal process granulomas, and Reinke's edema). Because both entities typically present with non-specific hoarseness or globus sensation, the difficulty of early screening and accurate differential diagnosis is substantially amplified.
Currently, the diagnosis of voice disorders relies heavily on laryngoscopy. However, owing to the unequal distribution of medical resources, primary and community care settings generally lack effective screening tools for laryngeal malignancies during initial consultations, often leading to delayed referrals for high-risk patients. Furthermore, there is a profound disparity in endoscopic interpretation expertise across different healthcare tiers. The visual features of certain precancerous lesions (such as dysplastic leukoplakia) and early-stage malignancies overlap considerably, resulting in a high risk of missed diagnoses or unnecessary biopsies of benign lesions. Therefore, systematically incorporating multidimensional indicators-including demographics (e.g., age), smoking and alcohol history, and clinical symptomatology-into risk assessment is crucial for the early detection of malignancies and the optimal allocation of healthcare resources.
In recent years, deep learning-based artificial intelligence (AI) has demonstrated tremendous potential in medical image feature extraction, capable of capturing subtle morphological textures imperceptible to the human eye. However, the oncogenesis and progression of laryngeal malignancies are driven by a confluence of multidimensional factors. When confronted with complex, real-world clinical scenarios, unimodal imaging models often suffer from decreased generalizability and elevated false-positive rates due to the absence of the patient's demographic, symptomatic, and behavioral exposure context. Real-world clinical decision-making is not an isolated image-interpretation task; rather, it requires the systematic integration of visual features with multidimensional clinical metadata. Developing an intelligent diagnostic framework capable of fusing multimodal data is therefore essential to overcome the application bottlenecks of current unimodal AI imaging tools.
Addressing these clinical pain points and technical limitations, this study leveraged a national multicenter cohort encompassing approximately 11,000 patients with voice disorders to develop and validate a two-stage, multimodal AI risk stratification and diagnostic framework. In the first stage, by integrating demographic characteristics, behavioral exposures, and clinical symptomatology, the investigators developed a non-invasive, low-cost Clinical Screening Model. This tool is designed to provide primary care settings and patients with an immediate, efficient early-warning system for malignancies. In the second stage, building upon this initial risk stratification, the investigators employed deep learning algorithms to extract microscopic visual features from endoscopic images, culminating in a Multimodal Diagnostic Model. This model achieves precise multiclass classification among laryngeal malignancies, common benign vocal fold lesions, and normal laryngeal anatomy. Furthermore, the investigators deployed a cloud-based web application to facilitate real-time risk estimation.
Ultimately, by providing this clinical-grade AI diagnostic assistant, this study aims to optimize the hierarchical screening and diagnostic pathways for voice disorders, thereby empowering general practitioners and primary care otolaryngologists to enhance the quality of clinical decision-making and diagnostic accuracy.
- Keywords
- Head and neck malignant lesions, Hypopharyngeal cancer, Laryngeal cancer, AI, machine learning, AI-assisted diagnosis
- Medical subject headings
- Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Head and Neck 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 |
|---|---|---|
| Patients with head and neck malignancies | Comprised patients with histopathologically confirmed head and neck malignant lesions, primarily including laryngeal and hypopharyngeal carcinomas. | |
| Patients without head and neck malignancies | Consisted of patients absent of malignant findings, encompassing individuals with normal laryngeal anatomy and those diagnosed with benign vocal fold lesions (e.g., polyps, cysts, and nodules). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngoscopic report diagnosis
those data will be collected via medical history records,"The laryngoscopic report diagnosis" primarily consists of detailed diagnostic classifications for various vocal fold and laryngeal pathologies.
Measured: During the first outpatient visit (Day 1)
Secondary outcomes (2)
Demographic data
Demographic data primarily includes demographic characteristics, behavioral habits, medical history, and lifestyle factors.
Measured: During the first outpatient visit (Day 1)
VHI-10
those data will be collected via questionnaire ,Voice-related quality of life was assessed using the Voice Handicap Index (VHI). Total scores range from 0 to 120. Higher scores indicate greater voice-related daily life handicap (worse outcome).
Measured: During the first outpatient visit(Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Apr 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Taikang Xianlin Drum Tower Hospital, Zhongda Hospital, Affiliated Cixi Hospital of Wenzhou Medical University, Changzhou Fourth People's Hospital, Nanjing Tongren Hospital, Nanjing Children's Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Shanghai Putuo District People's Hospital, Wuxi Huishan District People's Hospital, Fengyang County Hospital of Traditional Chinese Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532538
- Sponsor's protocol ID
- 2025123101
- Acronym
- ML-HNC-Risk
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Raw data will not be directly shared and will only be provided when necessary. All research codes involved in this study will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions: A Multidimensional Feature Study Integrating Demographics and Clinical Symptomatology
- ClinicalTrials.gov ID
- NCT07532538
- Acronym / sponsor ID
- ML-HNC-Risk / 2025123101
- Keywords
- Head and neck malignant lesions, Hypopharyngeal cancer, Laryngeal cancer, AI, machine learning, AI-assisted diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Taikang Xianlin Drum Tower Hospital, Zhongda Hospital, Affiliated Cixi Hospital of Wenzhou Medical University, Changzhou Fourth People's Hospital, Nanjing Tongren Hospital, Nanjing Children's Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Shanghai Putuo District People's Hospital, Wuxi Huishan District People's Hospital, Fengyang County Hospital of Traditional Chinese Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 16 Apr 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.
This study aims to develop and validate a clinical prediction model for the risk of head and neck cancerous lesions using deep learning combined with AI algorithms, based on multi-center clinical data.
Detailed description
Vocal health has emerged as a prominent public health challenge. Phonation relies on precise neuromuscular and respiratory coordination, a physiological process frequently compromised by systemic senescence, multimorbidity, and neuromuscular degeneration. This complex pathophysiological interplay makes it exceedingly difficult to clinically distinguish early-stage laryngeal malignancies from common benign voice disorders (e.g., vocal fold cysts, vocal process granulomas, and Reinke's edema). Because both entities typically present with non-specific hoarseness or globus sensation, the difficulty of early screening and accurate differential diagnosis is substantially amplified.
Currently, the diagnosis of voice disorders relies heavily on laryngoscopy. However, owing to the unequal distribution of medical resources, primary and community care settings generally lack effective screening tools for laryngeal malignancies during initial consultations, often leading to delayed referrals for high-risk patients. Furthermore, there is a profound disparity in endoscopic interpretation expertise across different healthcare tiers. The visual features of certain precancerous lesions (such as dysplastic leukoplakia) and early-stage malignancies overlap considerably, resulting in a high risk of missed diagnoses or unnecessary biopsies of benign lesions. Therefore, systematically incorporating multidimensional indicators-including demographics (e.g., age), smoking and alcohol history, and clinical symptomatology-into risk assessment is crucial for the early detection of malignancies and the optimal allocation of healthcare resources.
In recent years, deep learning-based artificial intelligence (AI) has demonstrated tremendous potential in medical image feature extraction, capable of capturing subtle morphological textures imperceptible to the human eye. However, the oncogenesis and progression of laryngeal malignancies are driven by a confluence of multidimensional factors. When confronted with complex, real-world clinical scenarios, unimodal imaging models often suffer from decreased generalizability and elevated false-positive rates due to the absence of the patient's demographic, symptomatic, and behavioral exposure context. Real-world clinical decision-making is not an isolated image-interpretation task; rather, it requires the systematic integration of visual features with multidimensional clinical metadata. Developing an intelligent diagnostic framework capable of fusing multimodal data is therefore essential to overcome the application bottlenecks of current unimodal AI imaging tools.
Addressing these clinical pain points and technical limitations, this study leveraged a national multicenter cohort encompassing approximately 11,000 patients with voice disorders to develop and validate a two-stage, multimodal AI risk stratification and diagnostic framework. In the first stage, by integrating demographic characteristics, behavioral exposures, and clinical symptomatology, the investigators developed a non-invasive, low-cost Clinical Screening Model. This tool is designed to provide primary care settings and patients with an immediate, efficient early-warning system for malignancies. In the second stage, building upon this initial risk stratification, the investigators employed deep learning algorithms to extract microscopic visual features from endoscopic images, culminating in a Multimodal Diagnostic Model. This model achieves precise multiclass classification among laryngeal malignancies, common benign vocal fold lesions, and normal laryngeal anatomy. Furthermore, the investigators deployed a cloud-based web application to facilitate real-time risk estimation.
Ultimately, by providing this clinical-grade AI diagnostic assistant, this study aims to optimize the hierarchical screening and diagnostic pathways for voice disorders, thereby empowering general practitioners and primary care otolaryngologists to enhance the quality of clinical decision-making and diagnostic accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck malignancies | – | –Comprised patients with histopathologically confirmed head and neck malignant lesions, primarily including laryngeal and hypopharyngeal carcinomas. |
| Patients without head and neck malignancies | – | –Consisted of patients absent of malignant findings, encompassing individuals with normal laryngeal anatomy and those diagnosed with benign vocal fold lesions (e.g., polyps, cysts, and nodules). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort comprised outpatients and inpatients from the otolaryngology departments of the participating medical centers, who underwent laryngoscopy primarily for initial presenting symptoms such as pharyngeal discomfort and hoarseness.
Key inclusion criteria (1 listed)
- Age ≥ 18 years old. Patients with complete clinical data information and laryngoscopic images.
Key exclusion criteria (1 listed)
- Refusal to sign the informed consent form. Incomplete clinical data. Known diagnosis of other head and neck malignancies (thyroid cancer, malignant parotid tumors, etc.
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
Laryngoscopic report diagnosis
Time frame: During the first outpatient visit (Day 1)
those data will be collected via medical history records,"The laryngoscopic report diagnosis" primarily consists of detailed diagnostic classifications for various vocal fold and laryngeal pathologies.
2 secondary outcomes
Demographic data
Time frame: During the first outpatient visit (Day 1)
VHI-10
Time frame: During the first outpatient visit(Day 1)
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 2 Sep 2026.
- Individual participant dataSharing planned: No. Raw data will not be directly shared and will only be provided when necessary. All research codes involved in this study will be made publicly available.
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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?
An observational study of Hypopharyngeal Cancer and Laryngeal Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 2 Sep 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 junyi Wang, master (+86 13309609232, songjiu3411@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngoscopic report diagnosis (time frame: During the first outpatient visit (Day 1)). 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 2 Sep 2026.