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| ID | Type | Description | Link |
|---|---|---|---|
| USCTU-FACS | |||
| ISRCTN41458548 | |||
| EU-20788 |
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RATIONALE: Following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care.
PURPOSE: This randomized clinical trial is following patients who have undergone surgery for stage I, stage II, or stage III colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to certainty of need for imaging follow-up, as determined by the local clinician (uncertain vs certain). Patients are randomized to 1 of 4 follow-up arms.
All patients receive a handbook from their physician detailing possible symptoms suggestive of disease recurrence.
Quality of life is assessed at baseline and then annually for 5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | |||
| computed tomography | Procedure | |||
| magnetic resonance imaging | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival by intention-to-treat analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | ||
| Cost of National Health Service (NHS) services utilized | ||
| NHS cost per life-year saved |
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DISEASE CHARACTERISTICS:
Diagnosis of primary colorectal cancer
Have undergone curative resection (i.e., no residual disease [R0])
Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy
Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL)
Has completed primary curative treatment, as deemed by hospital clinician
No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John N. Primrose, MD | University Hospital Southampton NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's Hospital | Recruiting | Burton-on-Trent | England | DE13 0RB | United Kingdom |
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| Cumberland Infirmary | Recruiting | Carlisle | England | CA2 7HY | United Kingdom |
|
| Saint Richards Hospital | Recruiting | Chichester | England | P019 4SE | United Kingdom |
|
| Queen Alexandra Hospital | Recruiting | Cosham | England | PO6 3LY | United Kingdom |
|
| Castle Hill Hospital | Recruiting | Cottingham | England | HU16 5JQ | United Kingdom |
|
| Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting | Crewe | England | CW1 4QJ | United Kingdom |
|
| Mayday University Hospital | Recruiting | Croydon | England | United Kingdom |
|
| Darent Valley Hospital | Recruiting | Dartford Kent | England | DA2 8DA | United Kingdom |
|
| Royal Derby Hospital | Recruiting | Derby | England | DE22 3NE | United Kingdom |
|
| Russells Hall Hospital | Recruiting | Dudley | England | DY1 2HQ | United Kingdom |
|
| Grantham and District Hospital | Recruiting | Grantham, Lincolnshire | England | NG31 8DG | United Kingdom |
|
| Harrogate District Hospital | Recruiting | Harrogate | England | HG2 7SX | United Kingdom |
|
| St. Mark's Hospital | Recruiting | Harrow | England | HA1 3UJ | United Kingdom |
|
| Wycombe General Hospital | Recruiting | High Wycombe | England | United Kingdom |
|
| Hinchingbrooke Hospital | Recruiting | Huntingdon | England | PE18 6NT | United Kingdom |
|
| West Middlesex University Hospital | Recruiting | Isleworth | England | TW7 6AF | United Kingdom |
|
| Leeds General Infirmary | Recruiting | Leeds | England | LS1 3EX | United Kingdom |
|
| Charing Cross Hospital | Recruiting | London | England | W6 8RF | United Kingdom |
|
| Mid Kent Oncology Centre at Maidstone Hospital | Recruiting | Maidstone | England | ME16 9QQ | United Kingdom |
|
| Queen's Medical Centre | Recruiting | Nottingham | England | NG7 2UH | United Kingdom |
|
| Derriford Hospital | Recruiting | Plymouth | England | PL6 8DH | United Kingdom |
|
| Scarborough General Hospital | Recruiting | Scarborough | England | YO12 6QL | United Kingdom |
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| Royal Shrewsbury Hospital | Recruiting | Shrewsbury | England | SY3 8XQ | United Kingdom |
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| Wexham Park Hospital | Recruiting | Slough, Berkshire | England | SL2 4HL | United Kingdom |
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| Solihull Hospital | Recruiting | Solihull | England | B91 2JL | United Kingdom |
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| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
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| St. Peter's Hospital | Recruiting | Surrey | England | KT 16 OPZ | United Kingdom |
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| Royal Cornwall Hospital | Recruiting | Truro, Cornwall | England | TR1 3LJ | United Kingdom |
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| Hillingdon Hospital | Recruiting | Uxbridge | England | UB8 3NN | United Kingdom |
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| Warrington Hospital NHS Trust | Recruiting | Warrington | England | WA5 1QG | United Kingdom |
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| Worcester Royal Hospital | Recruiting | Worcester | England | WR5 1DD | United Kingdom |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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