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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

junyi Wang, master contact

+86 13309609232

songjiu3411@outlook.com

China1 site, 1 recruiting
  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Junyi Wang, +86 13309609232, songjiu3411@outlook.com

    Recruiting

Other trials in China

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 groups in NCT07532538
Study groupRoleWhat they receive
Patients with head and neck malignanciesComprised patients with histopathologically confirmed head and neck malignant lesions, primarily including laryngeal and hypopharyngeal carcinomas.
Patients without head and neck malignanciesConsisted 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.

  1. 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)
  1. Demographic data

    Demographic data primarily includes demographic characteristics, behavioral habits, medical history, and lifestyle factors.

    Measured: During the first outpatient visit (Day 1)

  2. 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.

  1. First posted16 Apr 2026
  2. Study start30 Apr 2026
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

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
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.

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.

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