SYMPLIFY – assessing a multi-cancer early detection test in individuals referred with signs and symptoms of cancer
| ISRCTN | ISRCTN10226380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10226380 |
| IRAS number | 299310 |
| Secondary identifying numbers | OCTO_105, IRAS 299310, CPMS 49672 |
- Submission date
- 24/06/2021
- Registration date
- 13/08/2021
- Last edited
- 17/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Cancer is easier to treat if it is diagnosed early. The NHS has developed rapid referral pathways to allow cancers to be diagnosed earlier, but this requires us to run tests on a lot more people than turn out to have cancers. This creates worry for some people, may not be the most efficient use of NHS resources, a significant proportion of cancers are diagnosed via other routes, often when it is too late to cure them.
We know that the DNA from cancers can be detected in the blood early on and want to use this fact to detect cancers earlier than existing pathways. In this study we want to check the performance of one such multi-cancer early detection (MCED) test.
Who can participate?
People sent to one of 5 rapid referral pathways by their GP because they have symptoms that might be due to cancer.
What does the study involve?
People taking part in the study will have their diagnostic test(s) in the normal way, but will also give a blood sample and permission for us to check their health records later to see if they were diagnosed with cancer and what appointments and other tests they had.
At the end of the study, having tested the blood with the MCED test, we will understand more about how well it works in this group of people, and expect that this will help us to design another trial where we check how to use the test to decide who needs rapid referral to look for a possible cancer and what tests to use following a positive MCED result.
What are the possible benefits and risks of participating?
If someone participates, they will be contributing to important research into how to detect cancer early. This may benefit people in the future. If the GalleriTM test turns out to detect cancer early, we may be able to treat more cancers more successfully
We will do everything we can to make sure participants in this study don’t experience any harm. They will need to give a blood sample. Although this process is generally safe, they may experience discomfort or light-headedness, and there is a small risk of infection. If blood needs to be taken as part of their hospital care, the research blood sample will be taken at the same time.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
February 2021 to November 2022
Who is funding the study?
Grail Bio UK Ltd
Who is the main contact?
Sarah Pearson, octo-symplify@oncology.ox.ac.uk
Contact information
Public
OCTO, Dept of Oncology
University of Oxford
Old Road Campus Research Building
Old Road Campus
Roosevelt Drive
Oxford
OX3 7DQ
United Kingdom
 ORCID ID |
0000-0001-5386-1953 |
|---|---|
| Phone | +44 (0)1865 227170 |
| octo-symplify@oncology.ox.ac.uk |
Study information
| Study design | Prospective observational multi-centre cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | SYMPLIFY – Observational study to assess a multi-cancer early detection test in individuals referred with signs and symptoms of cancer |
| Study acronym | SYMPLIFY |
| Study hypothesis | To evaluate the performance of a multi-cancer early detection (MCED) test for the detection of invasive cancer and the identification of cancer signal origin |
| Ethics approval(s) | Approved 22/06/2021, London Central REC (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8225; londoncentral.rec@hra.nhs.uk), ref: 21/LO/0456) |
| Condition | Early detection of cancer |
| Intervention | Participants will be asked to give consent and provide a single blood sample during one visit to hospital. After that the participants have no further direct involvement, all follow-up is through collection of data. We collect data on participants at 3 and 12 months from registration into the study to find out whether or not they had a diagnosis of cancer. (We will also do a check at 9 months to collect any data that was not available at the 3 month timepoint). |
| Intervention type | Other |
| Primary outcome measure | At an interim analysis within 3 months of complete enrolment with complete analysis at 12 months of enrolment, measured by comparing blood sample analysis and patient notes: 1. Positive Predictive Value 2. Negative Predictive Value 3. Sensitivity 4. Specificity 5. Cancer signal origin accuracy |
| Secondary outcome measures | At an interim analysis within 3 months of complete enrolment with complete analysis at 12 months of enrolment, measured by comparing blood sample analysis and patient notes: 1. Concordance between referral pathway selected by GP and CSOs identified by MCED 2. Number of true positives/number of patients referred within each referral pathway |
| Overall study start date | 01/02/2021 |
| Overall study end date | 30/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 6,000 |
| Total final enrolment | 6238 |
| Participant inclusion criteria | 1. Participants referred to an RDC or relevant 2WW pathway to rule a cancer diagnosis in or out will be invited to participate in the study. 2. Willing and able to give informed consent for participation in the study. 3. Male or Female, aged 18 years or above. 4. Referred to a RDC or a gynae, lung, upper GI or lower GI cancer 2WW pathway. |
| Participant exclusion criteria | 1. Has a history of invasive or haematological malignancy diagnosed within the previous 3 years. 2. Has undergone definitive treatment for invasive or haematological malignancy in the last 3 years (adjuvant hormone therapy is permissible in this context). 3. Is taking cytotoxic or demethylating agents such as methotrexate. 4. Previous or current participation in another GRAIL study. “Participation” is defined as having signed consent and provided a blood sample. |
| Recruitment start date | 05/07/2021 |
| Recruitment end date | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
TQ2 7AA
United Kingdom
Truro
TR1 3HD
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
250 Euston Road
London
NW1 2PG
United Kingdom
N18 1QX
United Kingdom
York
YO31 8HE
United Kingdom
HU16 5JQ
United Kingdom
CF14 2TL
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Sponsor information
University/education
Clinical Trial and Research Governance Team
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 616480 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| 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 high-impact 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? |
|---|---|---|---|---|---|
| Results article | 20/06/2023 | 26/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | A comparison of cancer data obtained on-site during SYMPLIFY with data from English and Welsh national cancer registries | 09/10/2024 | 17/10/2024 | Yes | No |
Editorial Notes
17/10/2024: Publication reference added.
26/06/2023: Publication reference added.
20/04/2023: Chelsea and Westminster Hospital NHS Foundation Trust has been added to the trial participating centres.
27/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2021 to 30/11/2021.
2. The overall end date was changed from 30/09/2022 to 30/11/2022.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
07/09/2021: Internal review.
09/07/2021: Trial's existence confirmed by London Central REC.
