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

Testicular Germ Cell Tumor Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553371
• Other study ID #: CDR0000573199
• Secondary ID: ICR-RMH-NSGCTEU-
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2007
• Last updated: August 23, 2013
• Start date: April 2006

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Other:
• biomarker analysis

Procedure:
• computed tomography

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
Secondary	Rate of false positive abnormalities not due to NSGCT but due to benign process
Secondary	Rate of relapse following initial CT scan
Secondary	Number of abnormalities detected on second CT scan