Deep LearningNCT07532928
A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data
An observational study of Deep Learning and Head & Neck Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Learning, Head & Neck Squamous Cell Carcinoma
- How many people
- 571 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025.
Who may be able to join
- 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.
Who cannot join
- 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.
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
Department of Radiation Oncology, Nanfang Hospital, Southern Medical University
Guangzhou, 510000
About this study
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.
Read the 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.
- Conditions
- Deep Learning, Head & Neck Squamous Cell Carcinoma
- Keywords
- Head & neck squamous cell carcinoma, Deep Learning
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
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 |
|---|---|---|
| Postoperative concurrent chemoradiotherapy group | For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative concurrent chemoradiotherapy. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions over a treatment course of 6-7 weeks. Chemotherapy consisted of either cisplatin monotherapy (75 mg/m², once every 3 weeks) or a combination of cisplatin and 5-fluorouracil (cisplatin 75 mg/m², 5-fluorouracil 750 mg/m², once every 3 weeks), administered concurrently with radiotherapy. | |
| Postoperative radiotherapy group | For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative radiotherapy alone. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions, over a total treatment course of 6-7 weeks. | |
| Postoperative observation group | For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received no postoperative adjuvant therapy and were only followed up regularly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progress-free survival
From 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.
Measured: 2 years
Secondary outcomes (2)
2-year overall survival
From the initiation of treatment to the date of death from any cause or the cutoff date of follow-up.
Measured: 2 years
2-year recurrence-free survival
From 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.
Measured: 2 years
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 start15 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep LearningStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 571 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532928
- Sponsor's protocol ID
- NFEC-2025-364
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No