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

NCT ID: NCT00553371

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30

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.

Conditions

Testicular Germ Cell Tumor

Keywords

stage II malignant testicular germ cell tumor; stage III malignant testicular germ cell tumor

Interventions

biomarker analysis

Intervention Type: OTHER

computed tomography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Robert A. Huddart, MD

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Robert A. Huddart, MD

Role: primary

Other Identifiers

ICR-RMH-NSGCT

Identifier Type: -

Identifier Source: secondary_id

EU-20770

Identifier Type: -

Identifier Source: secondary_id

CDR0000573199

Identifier Type: -

Identifier Source: org_study_id