Oral CancerNCT03877159
Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
An observational study of Oral Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2017to 30 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Archived oral cancer tissue specimens within this single institute.
Who may be able to join
- Oral cancer
- Sufficient follow up data
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Robert Kennedy
London, SE19RT
Robert Kennedy, BSc PhD BDS
About this study
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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- There is no intervention.
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
There is no intervention. This is a retrospective study analysing archived tumour samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
Caspase-8 activity in oral cancer and its impact on disease progression
Molecular analysis of caspase-8 activity will be undertaken and correlated with tumour features and outcome.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start11 Nov 2017
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Kennedy, BSc PhD BDS, Principal investigator, KCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877159
- Sponsor's protocol ID
- 232080
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: No patient identifiable data is stored
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03877159
- Acronym / sponsor ID
- 232080
- Conditions
- Oral Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Archived oral cancer tissue specimens within this single institute.
Key inclusion criteria (2 listed)
- Oral cancer
- Sufficient follow up data
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention.There is no intervention. This is a retrospective study analysing archived tumour samples. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No. No patient identifiable data is stored
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kennedy, BSc PhD BDS principal investigator
KCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Kennedy, BSc PhD BDS (07815501088, robert.kennedy@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caspase-8 activity in oral cancer and its impact on disease progression (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.