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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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)

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 Summary:

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.


Sponsor: Royal Marsden NHS Foundation Trust

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 2, 2007
Date Started: April 2006
Date Completion:
Last Updated: August 23, 2013
Last Verified: October 2007