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Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer

Primary Purpose

Testicular Germ Cell Tumor

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
biomarker analysis
computed tomography
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Testicular Germ Cell Tumor focused on measuring stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic nonseminomatous germ cell tumor (NSGCT) at risk of developing late relapse of residual abnormality

    • Royal Marsden Hospital stage II-IV disease
  • Treatment for NSGCT completed within the past 5 to10 years

    • No evidence of disease after completion of chemotherapy, as demonstrated by negative CT scans within the past 3 years

PATIENT CHARACTERISTICS:

  • Willing to attend follow-up for five years
  • No contraindication to CT imaging

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

  • Royal Marsden - SurreyRecruiting

Outcomes

Primary Outcome Measures

Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan

Secondary Outcome Measures

Rate of false positive abnormalities not due to NSGCT but due to benign process
Rate of relapse following initial CT scan
Number of abnormalities detected on second CT scan

Full Information

First Posted
November 2, 2007
Last Updated
August 23, 2013
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00553371
Brief Title
Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer
Official Title
Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)
Study Type
Observational

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care. PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer.
Detailed Description
OBJECTIVES: To assess the frequency of relapse or recurrent abnormalities detected by CT scan in patients on long-term follow-up for metastatic nonseminomatous germ cell tumour (NSGCT). To assess the utility of CT scan-assessment in these patients. To assess the prognostic factors predictive of late relapse in NSGCT. OUTLINE: This is a multicenter study. Patients are screened by CT scan of the chest, abdomen, and pelvis for detectable abnormalities or indications of late relapse. Scans are classified as positive or negative, according to standard CT criteria, by a radiologist with expertise in testicular cancer imaging. Patients with negative scans are followed yearly by clinical examination and tumor marker assessment, and every 5 years by CT imaging. Additional follow-up is performed at the discretion of the attending physician. Patients with positive scans undergo confirmation of relapse, whenever possible, by surgical excision or biopsy and treatment is initiated according to best clinical practice. If the follow-up scan is equivocal, patients are advised to have a follow-up scan of the affected region in 6 months.

6. Conditions and Keywords

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

7. Study Design

Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Primary Outcome Measure Information:
Title
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
Secondary Outcome Measure Information:
Title
Rate of false positive abnormalities not due to NSGCT but due to benign process
Title
Rate of relapse following initial CT scan
Title
Number of abnormalities detected on second CT scan

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of metastatic nonseminomatous germ cell tumor (NSGCT) at risk of developing late relapse of residual abnormality Royal Marsden Hospital stage II-IV disease Treatment for NSGCT completed within the past 5 to10 years No evidence of disease after completion of chemotherapy, as demonstrated by negative CT scans within the past 3 years PATIENT CHARACTERISTICS: Willing to attend follow-up for five years No contraindication to CT imaging PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Huddart, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
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

12. IPD Sharing Statement

Learn more about this trial

Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer

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