Predicting Metastatic Oral Squamous Cell Carcinomas With... | NCT04543266

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

NCT04543266

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Sep 11, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Oral Squamous Cell Carcinoma

Interventions

Surgery

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Sep 8, 2020

First Posted Date

Sep 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2020

Last Update Posted Date

Sep 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Choi Siu-wai, Research Assistant Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Progressive Disease		Patients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease	Procedure: Surgery
Patients without Progressive Disease		Patients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Resection of tumors	Patients with Progressive Disease Patients without Progressive Disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Baseline of OSCC

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SW Choi, PhD	Contact	+85228590390		htswchoi@hku.hk
Chui Shan Chu, MMedSc	Contact	+85252227292		sunshine.c@connect.hku.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong	Recruiting	Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D009062	Mouth Neoplasms

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided