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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553371
First received: November 2, 2007
Last updated: August 23, 2013
Last verified: October 2007
  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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553371

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   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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: August 23, 2013
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 Diseases
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
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 21, 2014