NCT00553371

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
Last Updated

August 26, 2013

Status Verified

October 1, 2007

First QC Date

November 2, 2007

Last Update Submit

August 23, 2013

Conditions

Testicular Germ Cell Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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

Interventions

biomarker analysisOTHER
computed tomographyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Testicular Germ Cell TumorTesticular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Study Officials

  • Robert A. Huddart, MD

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

April 1, 2006

Last Updated

August 26, 2013

Record last verified: 2007-10

Locations

GB(1)