Oral Squamous Cell CarcinomaNCT04543266
Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning
An observational study of Oral Squamous Cell Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Application Management Team: PI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Sep 2020to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective, cohort study of all oral SCC patients who were treated with surgery for their primary oral SCC tumours at Queen Mary Hospital, from 1st October 2000 to 1st October 2019. The investigation will involve retrieval of paraffin embedded tissue blocks, determination of biomarker profile in these tissues, and retrieval of patient data from the Clinical Management System. No new patients will be prospectively recruited into the study.
Who may be able to join
- patients with oral squamous carcinoma
- received surgery from 1st October 2000 to 1st October 2019
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
SW Choi, PhD, htswchoi@hku.hk
Chui Shan Chu, BSc, sunshine.c@connect.hku.hk
About this study
Application Management Team:
PI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk
Read the detailed description
Eligibility Criteria:
- patients were diagnosed with a baseline disease of oral squamous carcinoma.
Exclusion Criteria:
- N/A
Sample size:
- ~500 subjects
Source of Data:
- The data, such as age and medical records, would be obtained from Hospital Authority Clinical Management System (HACMS)
Statistical analysis:
- machine learning will be applied into analysis plan
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Surgery
- Keywords
- OSCC; Oral cancer; Machine Learning
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Chemo-radiotherapy
Resection of tumors
| Study group | Role | What they receive |
|---|---|---|
| Patients with Progressive Disease | Patients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease Receives: Procedure: Surgery | |
| Patients without Progressive Disease | Patients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of the study are metastasis and recurrent disease
These outcomes will be entered as the dependent variables into the machine learning model
Measured: Baseline of OSCC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start7 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Choi Siu-wai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543266
- Sponsor's protocol ID
- UW19-704
- Status last verified
- Nov 2019
- First submitted
- 8 Sep 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning
- ClinicalTrials.gov ID
- NCT04543266
- Acronym / sponsor ID
- UW19-704
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- OSCC; Oral cancer; Machine Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Sep 2020 (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.
Application Management Team:
PI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk
Detailed description
Eligibility Criteria:
- patients were diagnosed with a baseline disease of oral squamous carcinoma.
Exclusion Criteria:
- N/A
Sample size:
- ~500 subjects
Source of Data:
- The data, such as age and medical records, would be obtained from Hospital Authority Clinical Management System (HACMS)
Statistical analysis:
- machine learning will be applied into analysis plan
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Progressive Disease | – | Procedure: SurgeryPatients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease |
| Patients without Progressive Disease | – | Procedure: SurgeryPatients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective, cohort study of all oral SCC patients who were treated with surgery for their primary oral SCC tumours at Queen Mary Hospital, from 1st October 2000 to 1st October 2019. The investigation will involve retrieval of paraffin embedded tissue blocks, determination of biomarker profile in these tissues, and retrieval of patient data from the Clinical Management System. No new patients will be prospectively recruited into the study.
Key inclusion criteria (2 listed)
- patients with oral squamous carcinoma
- received surgery from 1st October 2000 to 1st October 2019
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Chemo-radiotherapyResection of tumors | Procedure or surgery | Patients with Progressive Disease, Patients without Progressive Disease |
Primary outcome
The primary outcomes of the study are metastasis and recurrent disease
Time frame: Baseline of OSCC
These outcomes will be entered as the dependent variables into the machine learning model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Oral Squamous Cell Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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 11 Sep 2020. 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 Hong Kong. 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?
Contact SW Choi, PhD (+85228590390, htswchoi@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes of the study are metastasis and recurrent disease (time frame: Baseline of OSCC). 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 11 Sep 2020; AzTrials last refreshed its copy on 3 Nov 2026.