ClinicalTrials.gg
RecruitingNCT07532538ML-HNC-RiskUpdated Sep 2, 2026

A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions

An observational study in Hypopharyngeal Cancer, Laryngeal Cancer and Head and Neck Cancer, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Hypopharyngeal Neoplasms with a site in China — 16 open to participants now, 17 under way, 2 of them phase 3. Hypopharyngeal Neoplasms · China.

Started
2026
the only one that year
Observational
2 of 21
2 open now
Primary completion
2028-11
later than 15 of 16 live
Registered
21st of 21
by date
Lead sponsor
1 of 21
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Among the 21 studies in Hypopharyngeal Neoplasms with a site in China, this one is the only one that started in 2026, is one of 2 observational ones, reaches primary completion later than 15 of the 16 other live ones, and was the 21st registered.

Hypopharyngeal Neoplasms

148 studies on the registry are indexed under Hypopharyngeal Neoplasms; 45 are open to participants now.

Browse Hypopharyngeal Neoplasms studies →

Open to participants now

16 of the 21 studies in Hypopharyngeal Neoplasms with a site in China are open now. Recruiting first, the newest first:

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All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 38 Hypopharyngeal Neoplasms studies recruiting now, 23 (61%) set no upper age limit and 8 (21%) stop at 75 or younger; none take children under 18; 2 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · healthy volunteers too.

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02

Study 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 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.

03

Conditions studied

  • Hypopharyngeal Cancer
  • Laryngeal Cancer
  • Head and Neck Cancer

Keywords

  • Head and neck malignant lesions
  • Hypopharyngeal cancer
  • Laryngeal cancer
  • AI
  • machine learning
  • AI-assisted diagnosis
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥ 18 years old. Patients with complete clinical data information and laryngoscopic images.

Exclusion criteria

Exclusion Criteria:

Refusal to sign the form. Incomplete clinical data. Known diagnosis of other head and neck (thyroid cancer, malignant parotid tumors, etc.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  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.

    Time frame: During the first outpatient visit (Day 1)

Secondary outcomes

  1. Demographic data

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

    Time frame: 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).

    Time frame: During the first outpatient visit(Day 1)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Nov 2028, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2026
First posted
Apr 16, 2026
StartActual
Apr 30, 2026
Primary completionEst.
Nov 30, 2028
CompletionEst.
Nov 30, 2030
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07532538
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
First posted
Apr 16, 2026
Start date
Apr 30, 2026
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Sep 2, 2026

Study contacts

junyi Wang, master
Contact
songjiu3411@outlook.com
+86 13309609232

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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