Streamlining Staging of Colorectal cancer with Whole Body MRI
| ISRCTN | ISRCTN43958015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43958015 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/07/2012
- Registration date
- 25/07/2012
- Last edited
- 20/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Stuart Taylor
Scientific
Scientific
University College London
University College London Hospitals
Specialist X Ray Department
235 Euston Road
London
NW1 2BU
United Kingdom
| stuart.taylor1@nhs.net |
Study information
| Study design | Multicentre comparison |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please contact ctc.streamlineC@ucl.ac.uk to request a patient information sheet |
| Scientific title | Comprehensive staging of newly diagnosed colorectal cancer: prospective multi-centre comparison of whole body Magnetic Resonance Imaging with standard diagnostic imaging pathways |
| Study acronym | Streamline C |
| Study objectives | To evaluate whether early whole body magnetic resonance Imaging (WB-MRI) increases per patient sensitivity for metastasis in colorectal cancer compared to standard NICE-approved diagnostic pathways. More details can be found at http://www.hta.ac.uk/project/2804.asp |
| Ethics approval(s) | Camden and Islington Research Ethics Committee, 20 August 2012, ref: 12/LO/1176 |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 5. There are no treatment arms, every patient will receive a whole body MRI as part of the trial which takes about an hour. Aside from attending for the WB-MRI scan, patients shouldnt have to attend for any extra visits. All patients will be asked to complete quality of life forms (EQ-5D) at 0, 3, 6 and 9 months post staging. As part of the health economics portion of the trial, all patients will also be asked to complete patient diaries which will collect information about visits to the GP and hospital and about other medical tests and treatment for a year post staging. As part of the health psychology portion of the trial, 25 patients will take part in an interview (30 minutes) and 75 patients will be given questionnaires complete about their experience of staging at 0, 1, 3, 6, 9, and 12 months post staging. Follow-up CRFs will be completed for a year post-staging but there are no trial specific visits, this data is collected for the health economic portion of trial. |
| Intervention type | Other |
| Primary outcome measure | Per patient sensitivity for metastasis detection by whole body MRI (WB-MRI) compared to standard staging pathways in newly diagnosed colorectal cancer |
| Secondary outcome measures | 1. The time and test number taken to reach, and the nature of, the first major treatment decision based on WB-MRI in comparison to standard staging pathways. 2. Diagnostic accuracy of WB-MRI and conventional staging pathways for local tumour staging and detection of metastasis in comparison to an expert derived consensus reference standard. 3. Lifetime incremental cost and cost-effectiveness of staging using WB-MRI compared to standard diagnostic pathways. 4. Patient experience of staging using WB-MRI in comparison to standard diagnostic pathways and priorities placed by patients on differing attributes related to competing staging pathways. 5. Inter-observer variability in WB-MRI analysis and affect of diagnostic confidence on staging accuracy. 6. Diagnostic accuracy of limited T1 and diffusion weighted sequences compared to full multi-sequence WB-MRI protocols. |
| Overall study start date | 01/10/2012 |
| Completion date | 01/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 322 |
| Total final enrolment | 370 |
| Key inclusion criteria | 1. Adult patients (18 or over) with histologically proven or suspected colorectal cancer referred for staging. 2. Suspicion of colorectal cancer defined as: Presence of a mass highly suspicious for colorectal cancer on endoscopy, barium enema, CT colonography or other imaging which triggers staging investigations. 3. Patient must have given written informed consent and be willing to comply with the protocol intervention and follow up. |
| Key exclusion criteria | 1. Any psychiatric or other disorder likely to impact on informed consent 2. Evidence of severe or uncontrolled systemic disease which make it undesirable for the patient to participate in the trial 3. Pregnancy 4. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat) 5. Polyp cancer (because metastatic disease in these patients is vanishingly rare) |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 01/04/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
England
United Kingdom
| Website | http://www.ctc.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Not defined
NIHR Helath Technology Assessment Programme - HTA (UK) ref: 10/68/01
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | result | 01/07/2019 | 14/05/2019 | Yes | No |
| Results article | comparative results against ISRCTN50436483 | 01/12/2019 | 20/12/2019 | Yes | No |
Editorial Notes
20/12/2019: Publication reference added.
14/05/2019: Publication reference and total final enrolment added.
16/08/2018: The overall trial start date was changed from 01/04/2017 to 01/01/2019
