Testicular CancerNCT03142802
Low-Dose CT - Stage I Testicular Cancer
A study testing Low-dose computed tomography (LDCT) in people with Testicular Cancer, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Low-dose computed tomography (LDCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2005to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any medical conditions that render the patient ineligible to undergo the protocol or procedure
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
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.
- Conditions
- Testicular Cancer
- Being tested
- Low-dose computed tomography (LDCT)
- Keywords
- Testicular cancer, low-dose CT, CT scan
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomography (LDCT)Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with testicular germ cell cancer | Experimental | Patients with testicular germ cell cancer who have either been newly diagnosed, or have stage I cancer already on surveillance program will undergo conventional and low dose CT. Based on the imaging, they may undergo a surveillance program using low-dose CT. Receives: Diagnostic Test: Low-dose computed tomography (LDCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 years
Secondary outcomes (8)
Time on surveillance
Amount of time patient is on surveillance before detection of relapse.
Measured: 6 years
Amount of false positive rate of LDCTs
Measured: 6 years
Proportion of patients unsuitable for LDCT surveillance
Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality
Measured: 6 years
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.
Measured: 6 years
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)
Measured: 6 years
Proportion of disease-free survival
To document proportion of disease-free survival
Measured: 6 years
Proportion of overall survival
To document proportion of overall survival
Measured: 6 years
Amount of prospective documentation of treatment for testicular germ cell cancer relapse
To prospectively document the treatment types for patients who have relapsed.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start16 Sep 2005
- Primary completion14 Oct 2011
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients diagnosed with testicular germ cell cancer will undergo both standard and low dose CT scan of the abdomen and pelvis.
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Chung, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142802
- Sponsor's protocol ID
- 05-0436-CE
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2017
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chung P, O'Malley ME, Jewett MAS, Bedard PL, Panzarella T, Sturgeon J, Moore MJ, Hamilton R, Hansen AR, Anson-Cartwright L, Gospodarowicz M, Warde P. Detection of Relapse by Low-dose Computed Tomography During Surveillance in Stage I Testicular Germ Cell Tumours. Eur Urol Oncol. 2019 Jul;2(4):437-442. doi: 10.1016/j.euo.2018.08.031. Epub 2018 Oct 2.
PubMed 31277780
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
- ClinicalTrials.gov ID
- NCT03142802
- Acronym / sponsor ID
- 05-0436-CE
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer, low-dose CT, CT scan
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 Sep 2005 (actual)
- Primary completion
- 14 Oct 2011 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients diagnosed with testicular germ cell cancer will undergo both standard and low dose CT scan of the abdomen and pelvis.
| Arm | Type | Receives |
|---|---|---|
| Patients with testicular germ cell cancer | Experimental | Diagnostic Test: Low-dose computed tomography (LDCT)Patients with testicular germ cell cancer who have either been newly diagnosed, or have stage I cancer already on surveillance program will undergo conventional and low dose CT. Based on the imaging, they may undergo a surveillance program using low-dose CT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- any medical conditions that render the patient ineligible to undergo the protocol or procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: 1. Normal LDCT: - Patient continues on the study (i.e. continued surveillance) 2. 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 3. Elevated serum tumour markers or other evidence of metastatic disease: * Patient goes off study | Diagnostic test | Patients with testicular germ cell cancer |
Primary outcome
Difference in size of the retroperitoneal lymph node mass
Time frame: 9 years
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.
8 secondary outcomes
Time on surveillance
Time frame: 6 years
Amount of false positive rate of LDCTs
Time frame: 6 years
Proportion of patients unsuitable for LDCT surveillance
Time frame: 6 years
Proportion of patients who have to discontinue LDCT surveillance
Time frame: 6 years
Amount of prospective identification of first modality to detect relapse
Time frame: 6 years
Proportion of disease-free survival
Time frame: 6 years
Proportion of overall survival
Time frame: 6 years
Amount of prospective documentation of treatment for testicular germ cell cancer relapse
Time frame: 6 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 31277780Chung P, O'Malley ME, Jewett MAS, Bedard PL, Panzarella T, Sturgeon J, Moore MJ, Hamilton R, Hansen AR, Anson-Cartwright L, Gospodarowicz M, Warde P. Detection of Relapse by Low-dose Computed Tomography During Surveillance in Stage I Testicular Germ Cell Tumours. Eur Urol Oncol. 2019 Jul;2(4):437-442. doi: 10.1016/j.euo.2018.08.031. Epub 2018 Oct 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Chung principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose computed tomography (LDCT) in people with Testicular Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in size of the retroperitoneal lymph node mass (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.