Development of liquid biopsy in NHS Tayside: a genetic blood test for patients with pancreatic and colorectal cancer
| ISRCTN | ISRCTN93548632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93548632 |
| Secondary identifying numbers | 120879 |
- Submission date
- 24/01/2025
- Registration date
- 28/01/2025
- Last edited
- 28/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
At the moment, for both colorectal and pancreatic cancer, clinical decisions are based mainly on two modalities: radiology scans and blood biomarkers (tumour markers), the latter being specific for different types of cancer (CEA for colorectal and CA19-9 for pancreatic cancer, respectively). What we see on scans and how high or not the tumour markers are, dictate the appropriate treatment path for each patient, which usually includes a combination of surgery and/or chemotherapy-radiotherapy. However, since cancer harbours different types of mutations, often patients do not respond to treatment as expected and there are significant delays until this is reflected either on radiology images or on tumour marker levels. Apparently, there is an ongoing delay in optimising patients' treatment, limited by the existing diagnostic modalities. Therefore, the key to improving patient care and outcomes is to open a door and gain insight into tumour biology.
Circulating tumour DNA (ctDNA) is a form of cell-free DNA (genetic material) that originates from tumour cells and is found in the bloodstream. Liquid biopsy, a method that involves the analysis of ctDNA, offers a minimally invasive alternative to traditional tissue biopsies. This technique allows for the detection and monitoring of cancer by analysing blood samples. This is a study on ctDNA in patients with a new diagnosis of pancreatic and colorectal cancer.
Who can participate?
All adults in NHS Tayside with the above new diagnosis
What does the study involve?
The researchers will monitor the ctDNA levels in the participants' bloodstream during their treatment and over the surveillance period with recurring peripheral blood samples.
What are the possible benefits and risks of participating?
The main benefits of the study will be to assess this biomarker as an adjunct to identify disease progression or recurrence more easily. There are no associated risks for the participants, however, any results will not be communicated to them until the end of the study and they will not affect the decision-making process regarding their treatment.
Where is the study run from?
Ninewells Hospital in Dundee, Scotland within NHS Tayside (UK)
When is the study starting and how long is it expected to run for?
April 2024 to October 2028
Who is funding the study?
NHS Tayside Charitable Foundation (UK)
Who is the main contact?
Mr Georgios Gemenetzis, Georgios.gemenetzis2@nhs.scot
Contact information
Public, Scientific, Principal Investigator
Ninewells Hospital
James Arrott Dr
Dundee
DD2 1SG
United Kingdom
 ORCID ID |
0000-0002-0549-1369 |
|---|---|
| Phone | +44 (0)1382 660111 |
| georgios.gemenetzis2@nhs.scot |
Study information
| Study design | Single-centre longitudinal observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The Tayside Cancer Network (TAY.CA.N) Initiative: Utilisation of circulating tumour DNA (ctDNA) as a clinical biomarker for early detection of disease progression and recurrence in patients with pancreatic and colorectal cancer |
| Study acronym | TAYCAN |
| Study hypothesis | The primary hypothesis of this proposal suggests that the presence and ctDNA in the peripheral circulation of patients with pancreatic and colorectal cancer fluctuates according to tumour burden and therefore is directly correlated with presence of disease. As a result it can be utilised as a biomarker for early detection of disease recurrence or progression. |
| Ethics approval(s) |
Not yet submitted 27/01/2025, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email not provided), ref: Reference number not provided |
| Condition | Disease progression and recurrence in pancreatic and colorectal cancer |
| Intervention | Eligible patients will be recruited in the study and will undergo further genomic testing of the acquired biopsies for diagnostic purposes to determine the genetic profile of the primary tumours and recurring peripheral venous blood sampling to assess the presence and burden of said mutations in the bloodstream. |
| Intervention type | Other |
| Primary outcome measure | ctDNA levels for cancer-specific mutations measured with next-generation sequencing (NGS) at baseline and every 2 months between treatment modalities, until proof of disease recurrence or patient death/loss to follow up |
| Secondary outcome measures | Measurement in days of the lead changes in ctDNA levels compared to evidence of disease recurrence on traditional biomarkers (CA19-9, CEA) and on imaging (CT, MRI) |
| Overall study start date | 01/04/2024 |
| Overall study end date | 01/10/2028 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. All patients with a new diagnosis of pancreatic or colorectal cancer between ages 18-80 years 2. A cohort of healthy individuals (no previous cancer diagnosis) will be the control group and will need to provide a sample of peripheral blood samples to prove the lack of mutant genetic material in their bloodstream |
| Participant exclusion criteria | 1. For participants with a pancreatic or colorectal cancer diagnosis: past medical history of a different primary malignancy 2. For healthy participants: previous diagnosis of cancer |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 01/05/2027 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Office
Tayside Medical Science Centre (TASC)
Residency Block Level 3
George Pirie Way
Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382 383297 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.nhstayside.scot.nhs.uk/index.htm |
"ROR" |
https://ror.org/000ywep40 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/01/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the study will be communicated to NHS Tayside with a goal to establish ctDNA as a clinical diagnostic test in patients with pancreatic and colorectal cancer. Further planned publication in a peer-reviewed journal and presentation in national and international conferences is intended. |
| IPD sharing plan | The datasets generated and analysed will be available on request from Georgios Gemenetzis (Georgios.gemenetzis2@nhs.scot) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 28/01/2025 | No | No |
Additional files
Editorial Notes
27/01/2025: Study's existence confirmed by NHS Tayside Charitable Foundation.
