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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03142802
Other study ID # 05-0436-CE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 16, 2005
Est. completion date September 2025

Study information

Verified date December 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with primary germ cell cancer of the testicles confined to the testis can avoid adjuvant treatment by entering a surveillance protocol. In the surveillance protocol, patients are followed for up to ten years with serial computed tomography scans to detect recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may be associated with an increased risk of secondary malignancies. This study hypothesizes that low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence in this setting and will significantly reduce radiation exposure in this group of patients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 251
Est. completion date September 2025
Est. primary completion date October 14, 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Phase A: - Newly diagnosed testicular germ cell testicular cancer (GCT) with no clinical or tumour marker evidence of metastases - Stage I disease according to UICC stage groupings and currently on surveillance (in Year 1 of non-seminoma surveillance or year 1 or 2 of seminoma surveillance) - ECOG performance status 0 or 1 - Phase B: - Stage I disease according to UICC stage Groupings - Initial Low dose CT considered by study radiologist to be of sufficient quality to allow surveillance using LDCT protocol Exclusion Criteria: - any medical conditions that render the patient ineligible to undergo the protocol or procedure

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Low-dose computed tomography (LDCT)
In phase A of the study, patients will undergo conventional CT along with low dose CT. If patients have a normal conventional CT and a satisfactory low dose CT, they will move onto Phase B of the study in which they will undergo surveillance using low-dose CT. Three outcomes are possible with low-dose CT surveillance: Normal LDCT: - Patient continues on the study (i.e. continued surveillance) Suspicious LDCT: - Will undergo conventional CT and if results are normal, patient will continue on study. If conventional CT is abnormal, they will be taken off study Elevated serum tumour markers or other evidence of metastatic disease: Patient goes off study

Locations

Country Name City State
Canada University Health Network, Princess Margaret Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in size of the retroperitoneal lymph node mass The difference in size of lymph node mass at the time of relapse between low dose CT and conventional CT. This is to evaluate the effectiveness of using low-dose CT in patients undergoing surveillance. 9 years
Secondary Time on surveillance Amount of time patient is on surveillance before detection of relapse. 6 years
Secondary Amount of false positive rate of LDCTs 6 years
Secondary Proportion of patients unsuitable for LDCT surveillance Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality 6 years
Secondary Proportion of patients who have to discontinue LDCT surveillance Gather information on proportion of patients who had to discontinue LDCT surveillance due to poor image quality. 6 years
Secondary Amount of prospective identification of first modality to detect relapse To prospectively identify the first modality to detect relapse (patient symptoms, clinical examination, tumour marker, imaging) 6 years
Secondary Proportion of disease-free survival To document proportion of disease-free survival 6 years
Secondary Proportion of overall survival To document proportion of overall survival 6 years
Secondary Amount of prospective documentation of treatment for testicular germ cell cancer relapse To prospectively document the treatment types for patients who have relapsed. 6 Years
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