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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data
- ClinicalTrials.gov ID
- NCT07532928
- Acronym / sponsor ID
- NFEC-2025-364
- Conditions
- Deep Learning, Head & Neck Squamous Cell Carcinoma
- Keywords
- Head & neck squamous cell carcinoma, Deep Learning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 571 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
2-year progress-free survival
Time frame: 2 years
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.
2 secondary outcomes
2-year overall survival
Time frame: 2 years
2-year recurrence-free survival
Time frame: 2 years
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 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Deep Learning and Head & Neck Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University 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 7 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 20 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progress-free survival (time frame: 2 years). 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 20 Jul 2026.