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

August 23, 2013 updated by: Royal Marsden NHS Foundation Trust

Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Study Chair: Robert A. Huddart, MD, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000573199
  • ICR-RMH-NSGCT
  • EU-20770

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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