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

• Conditions: Testicular Germ Cell Tumor

• Registration Number: NCT00553371
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Study Timeline

• Study Start: 2006-04
• Status Verified: 2007-10
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Marsden - Surrey; 🇬🇧 Sutton, England, United Kingdom