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Trial record 44 of 11816 for:    Oral Cancer

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

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ClinicalTrials.gov Identifier: NCT03877159
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Oral Cancer Other: There is no intervention.

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
Actual Study Start Date : November 11, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020



Intervention Details:
  • Other: There is no intervention.
    There is no intervention. This is a retrospective study analysing archived tumour samples.


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Archived oral cancer tissue specimens within this single institute.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877159


Contacts
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Contact: Robert Kennedy, BSc PhD BDS 07815501088 robert.kennedy@kcl.ac.uk

Locations
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United Kingdom
Robert Kennedy Recruiting
London, United Kingdom, SE19RT
Contact: Robert Kennedy, BSc PhD BDS         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Robert Kennedy, BSc PhD BDS KCL

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03877159     History of Changes
Other Study ID Numbers: 232080
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No patient identifiable data is stored

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Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
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Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Carcinoma, Squamous Cell
Carcinoma
Stomatognathic Diseases