Improving the prediction of metastatic disease in primary colorectal cancer
| ISRCTN | ISRCTN95037515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95037515 |
| Secondary identifying numbers | 9423 |
- Submission date
- 10/08/2011
- Registration date
- 10/08/2011
- Last edited
- 16/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
We are carrying out a study to see if we can improve the imaging of colorectal cancer using a type of Computed Tomography (CT) scan known as perfusion CT. This type of scan can measure blood supply to tumours and we hope to use this information to improve our understanding of how tumours may behave and so future treatment.
Who can participate?
Men and women, aged 18 years or over, with suspected or proven colorectal cancer.
What does the study involve?
Participants will undergo an additional CT scan, which lasts approximately 2 minutes. This is carried out at the same time as the usual CT scan that participants would normally have. During the scan a dye will be administered through a needle in the participant's arm. Also, a bowel relaxant called buscopan will be given by injection to achieve a better quality scan image. Participants will continue to attend clinic visits for the first three years following the additional scan.
What are the possible benefits and risks of participating?
There may be no immediate benefit to those taking part. However the information we get from the study will help us to improve scan imaging of future patients and to possibly assess future cancer treatment. The main risk associated with the study is the increased radiation dose that comes with receiving an additional CT scan. The dye that is administered during the scan may cause mild side effects including nausea and vomiting, or a rash. An allergic reaction occurs rarely and may require drug treatment. Buscopan commonly causes a dry mouth. Other side effects are rare and include fast beating heart, shortness of breath and skin reactions.
Where is the study run from?
Bradford Royal Infirmary
Guy;s and St Thomas; Hospital, London
Western General, Edinburgh
University Hospital of North Staffordshire
Churchill Hospital, Oxford
Queen Alexandra Hospital, Portsmouth
Royal Cornwall Hospital, Truro
Northern General Hospital, Sheffield
Southampton General
Ninewells Hospital, Dundee
York Hospital
St James' University Hospital, Leeds
When is the study starting and how long is it expected to run for?
The study began recruiting in November 2011, and participants will be enrolled for 12-15 months. Recruitment will end in early 2013.
Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme
Who is the main contact?
PROSPECT study team, phs.prospect@phs.scot
Contact information
Scientific
Scottish Clinical Trials Research Unit (SCTRU)
Public Health Scotland (PHS)
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB
United Kingdom
| Phone | None provided |
|---|---|
| phs.prospect@phs.scot |
Study information
| Study design | Non-randomised, interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Improving the prediction of metastatic disease in primary colorectal cancer: prospective multicentre evaluation of a prognostic model of conventional predictive variables and novel variables derived from perfusion computed tomography |
| Study acronym | PROSPECT |
| Study objectives | To improve the prediction of metastatic disease in patients with colorectal cancer by developing a prognostic model based on disease free survival, that is superior to current practice, via prospective evaluation of both conventional predictive variables and novel variables derived from perfusion computed tomography (CT). |
| Ethics approval(s) | First MREC, 20/01/2011, ref: 10/H0713/84 |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 1. Perfusion computed tomography (CT) sequence 2. An additional perfusion CT sequence during the standard contrast-enhanced staging CT 3. Follow Up Length: 36 months |
| Intervention type | Other |
| Primary outcome measure | 1. To improve the prediction of metastatic disease in patients with colorectal cancer by developing a prognostic model based on disease-free survival 2. Measured at 3 and 5 years for each individual patient |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 31/01/2011 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 370; UK Sample Size: 370 |
| Total final enrolment | 326 |
| Key inclusion criteria | 1. Patients with suspected or proven (via optical colonoscopy and biopsy) colorectal cancer attending for pre-operative staging CT 2. Suspicion of colorectal cancer defined as: 2.1. Presence of a mass highly suspicious for colorectal cancer on barium enema, CT colonography or other imaging 2.2. Large bowel obstruction 2.3. Elevated serum CEA 3. Ability to provide informed written consent 4. Aged 18 years or over 5. Male or female participants |
| Key exclusion criteria | 1. Inability to provide informed written consent 2. Pregnancy 3. Renal impairment defined as serum creatinine >1150mmol/L 4. Previous iodinated contrast allergy 5. Inability to cannulate 6. Inability to lie flat 7. Weight greater than 200 kg (maximum weight capacity of CT scanner is 200 kg) |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
EH12 9EB
United Kingdom
Sponsor information
Hospital/treatment centre
The Strand
London
WC2R 3LS
England
United Kingdom
| Website | http://www.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 05/06/2024 | 11/06/2024 | Yes | No | |
| Results article | 16/04/2025 | 16/04/2025 | Yes | No |
Editorial Notes
16/06/2024: Publication reference added.
11/06/2024: Publication reference and total final enrolment added.
03/04/2024: The intention to publish date was changed from 31/03/2024 to 30/04/2024.
07/02/2024: The intention to publish date was changed from 31/12/2023 to 31/03/2024.
29/08/2023: The intention to publish date has been added.
15/05/2023: The primary contact email address was updated.
17/12/2020: The primary contact email address was updated.
17/07/2019: The overall trial end date was changed from 31/12/2012 to 31/12/2020.
04/12/2017: No publications found, verifying study status with principal investigator.
15/05/2012: The overall trial end date was changed from 31/05/2012 to 31/12/2012.
