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| Name | Class |
|---|---|
| Pelican Cancer Foundation | OTHER |
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Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.
A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative CT scan | No Intervention | CT-imaging of chest and abdomen / pelvis before surgery (standard treatment) | |
| Preoperative MRI scan | Experimental | Standard treatment plus an additional MRI scan before surgery |
|
| Observational | No Intervention | Observational only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative MRI scan | Other | Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI. | Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings | 3 years after last recruit |
| Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI. | Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI | 3 years after last recruit |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk. | Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI | 3 years after last recruit |
| To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Martin | Contact | +44 (0) 7749 655 817 | c.martin1@imperial.ac.uk | |
| Syvella Ellis | Contact | +44 (0) 7732 315 234 | giclinicaltrials@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gina Brown | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinchingbrooke Hospital | Recruiting | Huntingdon | Cambridgeshire | PE29 6NT | United Kingdom |
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Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI |
| 1 and 3 years after last recruit |
| To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk. | Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI | 5 years |
| To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk | CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI | 3 years after last recruit |
| To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI. | Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes | 3 years after last recruit |
| To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk. | Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI | 3 years after last recruit |
| To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk. | Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29) | 1 and 3 years after last recruit |
| To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk. | Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI | 3 years after last recruit |
| Leighton Hospital | Recruiting | Crewe | Cheshire | CW1 4QJ | United Kingdom |
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| University Hospital of North Tees | Recruiting | Stockton-on-Tees | County Durham | TS19 8PE | United Kingdom |
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| Croydon University Hospital | Recruiting | Thornton Heath | Croydon | CR7 7YE | United Kingdom |
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| Chesterfield Royal | Recruiting | Chesterfield | Derbyshire | SS4 5BL | United Kingdom |
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| Queen Alexandra Hospital | Recruiting | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
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| St Mark's Hospital | Recruiting | Middlesex | Harrow | HA1 3UJ | United Kingdom |
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| Maidstone Hospital | Recruiting | Maidstone | Kent | ME16 9QQ | United Kingdom |
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| Queen Elizabeth the Queen Mother Hospital | Recruiting | Margate | Kent | CT9 4AN | United Kingdom |
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| North Manchester General Hospital | Recruiting | Crumpsall | Manchester | M8 5RB | United Kingdom |
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| University Hospital of South Manchester & Manchester Royal Infirmary | Recruiting | Wythenshawe | Manchester | M23 9LT | United Kingdom |
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| Harrogate District Hospital | Recruiting | Harrogate | North Yorkshire | HG2 7SX | United Kingdom |
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| Musgrove Park Hospital | Recruiting | Taunton | Somerset | TA1 5DA | United Kingdom |
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| Yeovil District Hospital | Active, not recruiting | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Royal Marsden Hospital | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| Salisbury District Hospital | Recruiting | Salisbury | Whiltshire | SP2 8BJ | United Kingdom |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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