Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Testicular Germ Cell Tumor |
Other: biomarker analysis Procedure: computed tomography |
| 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) |
- 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
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
| Study Chair: | Robert A. Huddart, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00553371 History of Changes |
| Other Study ID Numbers: | CDR0000573199, ICR-RMH-NSGCT, EU-20770 |
| Study First Received: | November 2, 2007 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor |
Additional relevant MeSH terms:
|
Testicular Neoplasms Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Endocrine System Diseases Testicular Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013