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Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

Primary Purpose

Testicular Germ Cell Tumor

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
questionnaire administration
computed tomography
magnetic resonance imaging
quality-of-life assessment
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Testicular Germ Cell Tumor focused on measuring testicular seminoma, stage I malignant testicular germ cell tumor

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed seminoma of the testis Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis No evidence of any non-seminoma germ cell tumor elements Has undergone orchidectomy within the past 8 weeks Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy) Not planning to undergo adjuvant therapy PATIENT CHARACTERISTICS: Able to attend regular surveillance No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments) PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sites / Locations

  • Royal Bournemouth HospitalRecruiting
  • Sussex Cancer Centre at Royal Sussex County HospitalRecruiting
  • Bristol Haematology and Oncology CentreRecruiting
  • Addenbrooke's HospitalRecruiting
  • Gloucestershire Oncology Centre at Cheltenham General HospitalRecruiting
  • Huddersfield Royal InfirmaryRecruiting
  • Leeds Cancer Centre at St. James's University HospitalRecruiting
  • Leicester Royal InfirmaryRecruiting
  • Lincoln County HospitalRecruiting
  • UCL Cancer InstituteRecruiting
  • Charing Cross HospitalRecruiting
  • University College of London HospitalsRecruiting
  • Mid Kent Oncology Centre at Maidstone HospitalRecruiting
  • Christie HospitalRecruiting
  • James Cook University HospitalRecruiting
  • Northern Centre for Cancer Treatment at Newcastle General HospitalRecruiting
  • Northampton General HospitalRecruiting
  • Mount Vernon Cancer Centre at Mount Vernon HospitalRecruiting
  • Nottingham City HospitalRecruiting
  • Churchill HospitalRecruiting
  • Berkshire Cancer Centre at Royal Berkshire HospitalRecruiting
  • Cancer Research Centre at Weston Park HospitalRecruiting
  • Royal Marsden - SurreyRecruiting
  • Yeovil District HospitalRecruiting
  • Centre for Cancer Research and Cell Biology at Queen's University BelfastRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Velindre Cancer Center at Velindre HospitalRecruiting
  • Glan Clwyd HospitalRecruiting

Outcomes

Primary Outcome Measures

Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease

Secondary Outcome Measures

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
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

Full Information

First Posted
December 25, 2007
Last Updated
August 6, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00589537
Brief Title
Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
Official Title
Trial of Imaging and Schedule in Seminoma Testis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms. Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. Arm II: Patients undergo CT scan of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression. Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. Arm IV: Patients undergo MRI of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Germ Cell Tumor
Keywords
testicular seminoma, stage I malignant testicular germ cell tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
Secondary Outcome Measure Information:
Title
Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)
Title
Time on surveillance before detection of relapse
Title
Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)
Title
Extent of relapse according to International Germ Cell Cancer Collaborative Group classification
Title
Disease-free survival
Title
Overall survival
Title
Prospective evaluation of prognostic factors for relapse
Title
Number of false positive MRIs
Title
Resource use and costs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed seminoma of the testis Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis No evidence of any non-seminoma germ cell tumor elements Has undergone orchidectomy within the past 8 weeks Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy) Not planning to undergo adjuvant therapy PATIENT CHARACTERISTICS: Able to attend regular surveillance No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments) PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnathan Joffe, MD
Organizational Affiliation
Huddersfield Royal Infirmary
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Geldart
Phone
44-1202-726-088
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bloomfield, MD
Phone
44-1273-696-955 ext. 7686
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Braybrooke, MD
Phone
44-117-928-2418
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Williams, MD
Phone
44-122-321-7020
Email
michael.williams@addenbrookes.nhs.uk
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.R. Owen, MD
Phone
44-84-5422-4021
Email
roger.owen@glos.nhs.uk
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnathan Joffe, MD
Phone
44-1484-342-150
Email
jk.joffe@cht.nhs.uk
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-113-206-6400
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Benghiat, MD
Phone
44-116-258-5081
Email
albert.benghiat@uhl-tr.nhs.uk
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiagarajan Sreenivasant
Phone
44-1522-572-203
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Meyer, MD, BSc, MRCP, PhD
Phone
44-207-679-6731
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Savage, MD
Phone
44-20-8846-1419
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen J. Harland, MD
Phone
44-20-7380-9041
Email
stephen.harland@uclh.org
Facility Name
Mid Kent Oncology Centre at Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1622-729-000
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Logue
Phone
44-161-446-3407
Email
john.logue@christie-tr.nwest.nhs.uk
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Rathmell, MD
Phone
44-1642-854-750
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhona McMenemin
Phone
44-191-256-3588
Facility Name
Northampton General Hospital
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine M. Elwell, MD
Phone
44-1604-54-5246
Email
christine.elwell@ngh.nhs.uk
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordon J.S. Rustin, MD
Phone
44-1923-844-389
Email
grustin@nhs.net
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sokal
Phone
44-115-969-1169 ext. 57300
Facility Name
Churchill Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Protheroe, MD
Phone
44-186-522-6183
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Rogers, MD
Phone
44-118-987-7688
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert E. Coleman, MD, FRCP
Phone
44-114-226-5213
Email
r.e.coleman@sheffield.ac.uk
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert A. Huddart, MD
Phone
44-20-8661-3457
Email
robert.huddart@icr.ac.uk
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Parker
Phone
44-1935-384-345
Facility Name
Centre for Cancer Research and Cell Biology at Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7BL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seamus McAleer
Phone
44-28-9032-9241
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hutcheon, MD
Phone
44-1224-892-997
Email
andrew.hutcheon@arh.grampian.scot.nhs.uk
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff White, MD
Phone
44-141-301-7056
Email
jeff.white@northglasgow.scot.nhs.uk
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim Barber, MD
Phone
44-29-2061-5888
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Champion
Phone
44-1745-534-432

12. IPD Sharing Statement

Citations:
PubMed Identifier
35298280
Citation
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.
Results Reference
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Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

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