A Phase 3 interventional study of questionnaire administration and computed tomography in Testicular Germ Cell Tumor, sponsored by Medical Research Council. Status unknown at 29 sites in United Kingdom. Open to male participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by Medical Research Council · Phase 3, Interventional, and Diagnostic
RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.
PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.
Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.
85 studies on the registry are indexed under Testicular Germ Cell Tumor; 10 are open to participants now.
This study's planned enrollment of 660 is above the median of 46 across 54 interventional studies indexed under Testicular Germ Cell Tumor.
Browse Testicular Germ Cell Tumor studies →Medical Research Council is the lead sponsor of 68 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
confirmed seminoma of the testis
Has undergone orchidectomy within the past 8 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)
Time on surveillance before detection of relapse
Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)
Extent of relapse according to International Germ Cell Cancer Collaborative Group classification
Disease-free survival
Overall survival
Prospective evaluation of prognostic factors for relapse
Number of false positive MRIs
Resource use and costs
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Medical Research Council