NCT04543266

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 11, 2020

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

September 8, 2020

Last Update Submit

September 9, 2020

Conditions

Keywords

OSCC; Oral cancer; Machine Learning

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

SurgeryPROCEDURE

Resection of tumors

Also known as: Chemo-radiotherapy
Patients with Progressive DiseasePatients without Progressive Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Embedded blocks will be used for protein expressions

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckMouth Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Central Study Contacts

SW Choi, PhD

CONTACT

Chui Shan Chu, MMedSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 10, 2020

Study Start

September 7, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

September 11, 2020

Record last verified: 2019-11

Locations