Head and Neck CancerNCT06570486
Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors
An observational study of Head and Neck Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Apr 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Head and neck tumor postoperative patient transferred to icu
Who may be able to join
- Patients after head and neck tumors;
- older than 18 years.
Who cannot join
- Patients transferred to ICU twice after head and neck tumors;
- Patients with unplanned transfer to the ICU.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 52100
Zhengfei Yang, 13632370949, yangzhengfei@vip.163.com
About this study
This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
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 |
|---|---|---|
| training group | For training models | |
| test group | Used to validate the model | |
| Prospective cohort | For the prospective validation of the model |
What is being measured
The primary outcome is the main question the study is designed to answer.
roll-out icu
The time of patient transfer from ICU to the general ward was set as transfer out
Measured: From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570486
- Sponsor's protocol ID
- SYSKY-2024-403-01
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If others need it, they can apply to us for the data, and we will provide it.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT06570486
- Acronym / sponsor ID
- SYSKY-2024-403-01
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| training group | – | –For training models |
| test group | – | –Used to validate the model |
| Prospective cohort | – | –For the prospective validation of the model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck tumor postoperative patient transferred to icu
Key inclusion criteria (2 listed)
- Patients after head and neck tumors;
- older than 18 years.
Key exclusion criteria (2 listed)
- Patients transferred to ICU twice after head and neck tumors;
- Patients with unplanned transfer to the ICU.
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
roll-out icu
Time frame: From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days
The time of patient transfer from ICU to the general ward was set as transfer out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No. If others need it, they can apply to us for the data, and we will provide it.
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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. This study is not recruiting at the moment.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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 Head and Neck Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
roll-out icu (time frame: From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days). 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 26 Aug 2024.