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Clinical Trials/NCT00553371
NCT00553371
Unknown
Not Applicable

Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)

Royal Marsden NHS Foundation Trust1 site in 1 country300 target enrollmentApril 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Testicular Germ Cell Tumor
Sponsor
Royal Marsden NHS Foundation Trust
Enrollment
300
Locations
1
Primary Endpoint
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
TBD
Last Updated
12 years ago
Study Type
Observational
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

Study Sites (1)

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