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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000574037 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20771 | |||
| ISRCTN65987321 |
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RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.
PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.
Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | |||
| computed tomography | Procedure | |||
| magnetic resonance imaging | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) | ||
| Time on surveillance before detection of relapse | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed seminoma of the testis
No evidence of any non-seminoma germ cell tumor elements
Has undergone orchidectomy within the past 8 weeks
Not planning to undergo adjuvant therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Johnathan Joffe, MD | Huddersfield Royal Infirmary | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Bournemouth Hospital | Recruiting | Bournemouth | England | BH7 7DW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35298280 | Derived | Joffe JK, Cafferty FH, Murphy L, Rustin GJS, Sohaib SA, Gabe R, Stenning SP, James E, Noor D, Wade S, Schiavone F, Swift S, Dunwoodie E, Hall M, Sharma A, Braybrooke J, Shamash J, Logue J, Taylor HH, Hennig I, White J, Rudman S, Worlding J, Bloomfield D, Faust G, Glen H, Jones R, Seckl M, MacDonald G, Sreenivasan T, Kumar S, Protheroe A, Venkitaraman R, Mazhar D, Coyle V, Highley M, Geldart T, Laing R, Kaplan RS, Huddart RA; TRISST Trial Management Group and Investigators. Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST). J Clin Oncol. 2022 Aug 1;40(22):2468-2478. doi: 10.1200/JCO.21.01199. Epub 2022 Mar 17. |
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| Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) |
| Extent of relapse according to International Germ Cell Cancer Collaborative Group classification |
| Disease-free survival |
| Overall survival |
| Prospective evaluation of prognostic factors for relapse |
| Number of false positive MRIs |
| Resource use and costs |
| Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting | Brighton | England | BN2 5BF | United Kingdom |
|
| Bristol Haematology and Oncology Centre | Recruiting | Bristol | England | BS2 8ED | United Kingdom |
|
| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
|
| Gloucestershire Oncology Centre at Cheltenham General Hospital | Recruiting | Cheltenham | England | GL53 7AN | United Kingdom |
|
| Huddersfield Royal Infirmary | Recruiting | Huddersfield, West Yorks | England | HD3 3EA | United Kingdom |
|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
|
| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
|
| Lincoln County Hospital | Recruiting | Lincoln | England | LN2 5QY | United Kingdom |
|
| UCL Cancer Institute | Recruiting | London | England | NW3 2QG | United Kingdom |
|
| Charing Cross Hospital | Recruiting | London | England | W6 8RF | United Kingdom |
|
| University College of London Hospitals | Recruiting | London | England | WIT 3AA | United Kingdom |
|
| Mid Kent Oncology Centre at Maidstone Hospital | Recruiting | Maidstone | England | ME16 9QQ | United Kingdom |
|
| Christie Hospital | Recruiting | Manchester | England | M20 4BX | United Kingdom |
|
| James Cook University Hospital | Recruiting | Middlesbrough | England | TS4 3BW | United Kingdom |
|
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
|
| Northampton General Hospital | Recruiting | Northampton | England | NN1 5BD | United Kingdom |
|
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting | Northwood | England | HA6 2RN | United Kingdom |
|
| Nottingham City Hospital | Recruiting | Nottingham | England | NG5 1PB | United Kingdom |
|
| Churchill Hospital | Recruiting | Oxford | England | OX3 7LJ | United Kingdom |
|
| Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting | Reading | England | RG1 5AN | United Kingdom |
|
| Cancer Research Centre at Weston Park Hospital | Recruiting | Sheffield | England | S1O 2SJ | United Kingdom |
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| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
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| Yeovil District Hospital | Recruiting | Yeovil | England | BA21 4AT | United Kingdom |
|
| Centre for Cancer Research and Cell Biology at Queen's University Belfast | Recruiting | Belfast | Northern Ireland | BT9 7BL | United Kingdom |
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| Aberdeen Royal Infirmary | Recruiting | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
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| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | Scotland | G11 6NT | United Kingdom |
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| Velindre Cancer Center at Velindre Hospital | Recruiting | Cardiff | Wales | CF14 2TL | United Kingdom |
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| Glan Clwyd Hospital | Recruiting | Rhyl, Denbighshire | Wales | LL 18 5UJ | United Kingdom |
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| ID | Term |
|---|---|
| C563236 | Testicular Germ Cell Tumor |
| D018239 | Seminoma |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
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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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