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A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data

A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07532928
Enrollment
571
Registered
2026-04-16
Start date
2025-08-15
Completion date
2028-12-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Learning, Head & Neck Squamous Cell Carcinoma

Keywords

Head & neck squamous cell carcinoma, Deep Learning

Brief summary

Based on multimodal data, the investigators establish a dynamic deep learning model to conduct prognostic risk assessment for patients and recommend the 'most suitable' treatment/follow-up regimen after radical treatment, assisting clinicians in improving homogenized evaluation levels and achieving individualized precision therapy, thereby providing scientific evidence for the currently widely debated selection of postoperative adjuvant therapy in locally advanced head and neck squamous cell carcinoma patients.

Detailed description

This clinical study is an observational bidirectional study. A retrospective cohort is used to train the model for recurrent risk prediction and adjuvant treatment decision-making, while a prospective cohort serves as an external validation set to verify the model performance.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER
Peking University Shenzhen Hospital
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>= 18 years. * Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025. * Patients who either seek medical treatment after June 2022 or sought medical treatment before that but have not lost contact with the hospital for more than 1 year are required to sign the informed consent form voluntarily. * Newly diagnosed head and neck squamous cell carcinoma (HNSCC) confirmed by histopathology. * Locally advanced disease without distant metastasis. * Complete clinical data (including patient demographics, tumor characteristics, treatment details, and prognostic variables). * Availability of MRI, CT, or PET-CT images before and after radical treatment.

Exclusion criteria

* History of or coexisting secondary malignancies. * Lack of definitive radical treatment. * Absence of baseline or follow-up imaging (MRI/CT/PET-CT). * Investigator-determined unsuitability for study participation.

Design outcomes

Primary

MeasureTime frameDescription
2-year progress-free survival2 yearsFrom the initiation of treatment to the date of tumor progression (including local recurrence, regional lymph node metastasis, and distant metastasis) or tumor-related death, whichever occurs first. If no progression event was observed by the cutoff date of follow-up, the last follow-up date was used.

Secondary

MeasureTime frameDescription
2-year overall survival2 yearsFrom the initiation of treatment to the date of death from any cause or the cutoff date of follow-up.
2-year recurrence-free survival2 yearsFrom the initiation of treatment to the date of first local tumor recurrence, regional lymph node metastasis, or tumor-related death, whichever occurs first. If no such event was observed by the cutoff date of follow-up, the last follow-up date was used.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026