Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer
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|ClinicalTrials.gov Identifier: NCT00553371|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 5, 2007
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment|
|Testicular Germ Cell Tumor||Other: biomarker analysis Procedure: computed tomography|
- 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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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 Start Date :||April 2006|
- Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553371
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Robert A. Huddart, MD 44-20-8661-3457 firstname.lastname@example.org|
|Study Chair:||Robert A. Huddart, MD||Royal Marsden NHS Foundation Trust|