Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma

July 21, 2020 updated by: Guy's and St Thomas' NHS Foundation Trust
Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. Caspase-8 is a key enzyme involved in controlling cell death. This study examines the importance of caspase-8 in oral cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. The caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. This study will perform DNA sequencing to determine if the gene is wild-type (not mutated). The abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. The levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. Results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. This will improve the understanding of the importance of caspase-8 in oral cancer.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, SE19RT
        • Recruiting
        • Robert Kennedy
        • Contact:
          • Robert Kennedy, BSc PhD BDS

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Archived oral cancer tissue specimens within this single institute.

Description

Inclusion Criteria:

  • Oral cancer
  • Sufficient follow up data

Exclusion Criteria:

  • Patient has indicated that they do not wish their tissue to be used for research.
  • . The quantity or quality of tissue is too little or poor to provide adequate material without significant reserve.
  • The material contains bone.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caspase-8 activity in oral cancer and its impact on disease progression
Time Frame: Up to 3 years
Molecular analysis of caspase-8 activity will be undertaken and correlated with tumour features and outcome.
Up to 3 years

Collaborators and Investigators

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

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Robert Kennedy, BSc PhD BDS, KCL

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)

November 11, 2017

Primary Completion (Anticipated)

January 30, 2021

Study Completion (Anticipated)

January 30, 2021

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No patient identifiable data is stored

Drug and device information, study documents

Studies a U.S. FDA-regulated drug 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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