NHS Cancer Vaccine Launch Pad (NHS CVLP)
| ISRCTN | ISRCTN13053675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13053675 |
| IRAS number | 325291 |
| Secondary identifying numbers | CPMS 57835, IRAS 325291 |
- Submission date
- 09/07/2024
- Registration date
- 09/10/2024
- Last edited
- 09/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Personalised cancer vaccines are a type of cancer treatment designed to target an individual’s unique cancer cells. They are created by analysing a patient’s tumour and identifying specific DNA changes that are unique to that cancer, then using that information to create a vaccine tailored to that patient. The intention is that the cancer vaccine will stimulate the immune system to specifically recognise and destroy the cancer cells.
The NHS Cancer Vaccine Launch Pad (CVLP) is looking to find people who may be able to take part in research trials for personalised vaccines to treat cancer. By supporting these trials, the CVLP aims to speed up the development of personalised treatments for cancer patients.
Who can participate?
NHS cancer patients in England aged over 16 years with capacity to consent.
What does the study involve?
Upon consent, the following will occur:
1. Small sections of the tumor will be cut from the diagnostic block by a histopathologist (a doctor who specializes in studying tissues). These sections will be sent to CVLP partners for nucleic acid extraction and sequencing. Nucleic acids are molecules like DNA and RNA that carry genetic information.
2. A blood sample, up to 30 milliliters, will be drawn and sent to CVLP partners. This sample may be tested for germline nucleic acid (genetic information you were born with) and tumor circulating free DNA (genetic material released by the tumor into the bloodstream).
3. Baseline demographic (like age and gender) and clinical data will be recorded by the clinical or research team and sent with the biological material in a pseudonymised form (using codes instead of names to protect your identity). This data will also be centrally held by Southampton Clinical Trials Unit (SCTU) to coordinate with cancer vaccine trial partners and sites. A clinical liaison team will oversee this process.
4. During Phase 1, sequencing data will be held by industry partners. If you are eligible for a cancer vaccine trial, the clinical liaison team will inform your clinical team and local trial sites. Pseudonymised codes will be used to identify patients when communicating with clinical teams or linking patients with NHS cancer vaccine trial sites. Any other information shared outside the NHS CVLP framework will also be pseudonymised.
5. If you are eligible for a cancer vaccine trial, your home clinical or research team, or the team at the nearest cancer vaccine trial site, will approach you for further discussion and a separate consent.
What are the possible benefits and risks of participating?
By taking part in the CVLP, participants might be able to take part in a research trial and receive personalised cancer vaccine treatment before it is widely available. For participants who receive this personalised treatment, it may reduce the chance of their cancer growing or coming back.
Not everyone will be suitable to take part in a research trial and the research trial may not benefit all participants directly. This is because we are still finding out how effective the treatment might be.
Participants can also benefit from the knowledge that they are helping medical research to improve cancer treatment. The tests and treatments being used were developed with the help of participants who took part in research years ago. The more participants that take part in research, the faster progress can be made as more human samples can be studied.
Where is the study run from?
The study is coordinated by the Southampton Clinical Trials Unit and is being run in NHS hospitals in England. The study is sponsored by NHS England.
When is the study starting and how long is it expected to run for?
May 2023 to December 2030
Who is funding the study?
NHS England (UK)
Who is the main contact?
Southampton Clinical Trials Unit at cvlp@soton.ac.uk
Contact information
Scientific
Southampton Clinical Trials Unit, Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
| Phone | +44 2381205154 |
|---|---|
| cvlp@soton.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Other |
| Participant information sheet | 45760 NHSE CVLP Participant Information Sheet v8 22Mar2024.pdf |
| Scientific title | Establishing a UK platform to collect tumour samples and perform DNA/RNA sequencing for the development of personalised cancer vaccines |
| Study acronym | CVLP |
| Study hypothesis | The objectives of the NHS Cancer Vaccine Launch Pad (CVLP) are to: 1. Identify cancer patients undergoing resection or biopsy of their tumours who could be eligible for personalised mRNA therapies such as cancer vaccines. 2. Create a pathway for collection and transfer of tumour samples, blood samples and pseudonymised clinical data during routine NHS care. 3. Send samples for DNA extraction, molecular analysis and sequencing initially in partnership with industry (Phase 1) and later to be performed by the NHS Genomic Medicine Service (Phase 2). 4. Use the results to accelerate access of eligible cancer patients to cancer vaccine trials. The programme aims to profile up to 10,000 tumour samples in a phased approach over 7 years. To achieve this we will enrol patients diagnosed with different cancers and seek their consent for: 1. Collection of surplus tumour biopsies or surgical resection samples to be sent to genetic testing laboratories for DNA or RNA extraction and sequencing. 2. Collection of a blood sample to perform relevant tests for cancer vaccines, eg: circulating free tumour DNA or sequencing of healthy cells to compare to the tumour. 3. Collection of routine clinical data on demographics, staging, diagnostic tests, treatment and outcomes. 4. The linkage of this data in a database held by a central team to co-ordinate between clinical sites, industry partners and cancer vaccine trial sites. 5. Onwards referral of potentially eligible patients to CV trials or linked research studies provided relevant research ethics approval has been granted - for which separate consent will be sought. No specific therapeutic intervention will be carried out under this protocol and any activities for the CVLP will happen in addition to routine genetic testing that is carried out as standard of care. If CV gain regulatory approval we hope the CVLP pathway will become part of routine care. |
| Ethics approval(s) |
Approved 20/08/2023, East of England – Essex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8177; essex.rec@hra.nhs.uk), ref: 23/EE/0178 |
| Condition | Cancer vaccine studies in various cancer types |
| Intervention | Eligible patients with a number of different cancers will be approached around the time of diagnostic biopsy or surgical resection. This could be either during their initial diagnosis of cancer or at the time of recurrence. In all cases the patient will be aware that a diagnosis of cancer has already been made, or is a strong possibility. The patient will be approached by the clinical team managing their care to discuss the study and a standard patient information sheet will be provided. Patients who agree to take part will have their informed consent confirmed and recorded by one of the clinical team or a research associate. Following consent, the following will occur: 1. Cuttings of sections of tumour from the diagnostic block under the supervision of a histopathologist, for forwarding to CVLP partners (Phase 1) for extraction and sequencing of nucleic acid. 2. Drawing of a blood sample (up to 30mls) also for forwarding to CVLP partners. Potential tests performed on blood samples include germline extraction of nucleic acid for the comparison with the tumour sample or tumour circulating free tumour DNA. 3. Recording of baseline demographic and clinical data will be done by the clinical or research team. This will be sent along with biological material in a pseudonymised form. Data will be held centrally by the Southampton Clinical Trials Unit (SCTU). 4. During Phase 1 sequencing data will be held by industry partners. If a patient is deemed to be eligible for a cancer vaccine trial this will be fed back to the clinical liaison team who will inform the clinical teams and any local trial sites. The pseudonymised codes will only be used for re-identifying patients when communicating with the clinical team or to link patients with NHS cancer vaccine trial sites. Any other information shared outside the NHS CVLP framework will be pseudonymised. 5. If a patient is deemed eligible for a cancer vaccine trial they will be approached by either their home clinical or research team, or by the team at the nearest cancer vaccine trial site for further discussion and a separate consent. |
| Intervention type | Other |
| Primary outcome measure | 1. Number of participants recruited to the CVLP by September 2024 2. Number of participants recruited to the CVLP measured every 12 months until study closure 3. Proportion of eligible patients approached that consent to participate in the CVLP measured every 12 months until study closure 4. Proportion of tumour samples available for analysis measured at 2 weeks post consent to a cancer vaccine trial 5. Number of participants proceeding to participate in a cancer vaccine trial measured monthly until study closure |
| Secondary outcome measures | Number of sequencing outputs from NHS laboratories used for manufacturing of therapeutic personalised cancer vaccines measured every 12 months until study closure |
| Overall study start date | 01/05/2023 |
| Overall study end date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 10,000 |
| Participant inclusion criteria | 1. Be over the age of 16 years 2. Have a tumour which has been, or will be resected or biopsied 3. Have the capacity to consent to involvement in the CVLP 4. Have sufficient tumour available for genomic analyses |
| Participant exclusion criteria | 1. Under the age of 16 years 2. Incapable of giving informed consent |
| Recruitment start date | 31/08/2024 |
| Recruitment end date | 01/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
London
SE13 6LH
United Kingdom
Woolwich
London
SE18 4QH
United Kingdom
Guildford
GU2 7XX
United Kingdom
Brighton
BN2 5BE
United Kingdom
St. Leonards-on-sea
TN37 7RD
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Romford
RM7 0AG
United Kingdom
Charter Way
Turner Road
Colchester
CO4 5JL
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
High Wycombe
HP11 2TT
United Kingdom
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Warwick
CV34 5BW
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Walsall
WS2 9PS
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Oldham
OL1 2JH
United Kingdom
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Rochdale
OL12 0NB
United Kingdom
Leeds
LS9 7TF
United Kingdom
Leeds
LS1 3EX
United Kingdom
Sheffield
S10 2SJ
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
Taunton
TA1 5DA
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Barnstaple
EX31 4JB
United Kingdom
Bristol
BS2 8ED
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Bath
BA1 3NG
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Lancaster
LA1 4RP
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Hensingham
Whitehaven
CA28 8JG
United Kingdom
Sunderland
SR4 7TP
United Kingdom
South Shields
NE34 0PL
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
North Shields
NE29 8NH
United Kingdom
Sponsor information
Government
Wellington House, 133-155 Waterloo Road
London
SE1 8UG
England
United Kingdom
| england.cancervaccinelaunchpad@nhs.net |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 8 | 22/03/2024 | 23/07/2024 | No | Yes |
Additional files
Editorial Notes
09/07/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
