Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning

September 9, 2020 updated by: Dr. Choi Siu-wai, The University of Hong Kong

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • patients with oral squamous carcinoma
  • received surgery from 1st October 2000 to 1st October 2019

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Progressive Disease
Patients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease
Procedure: Surgery
Resection of tumors
Other Names:
  • Chemo-radiotherapy
Patients without Progressive Disease
Patients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease
Procedure: Surgery
Resection of tumors
Other Names:
  • Chemo-radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline of OSCC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW19-704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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