An interventional study of WATChmAN Active Surveillance and In-person Active Surveillance in Testicular Cancer, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Other
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Among 21 studies in Testicular Neoplasms with a site in Canada — 4 open to participants now, 7 under way, none of them phase 3. Testicular Neoplasms · Canada.
Among the 21 studies in Testicular Neoplasms with a site in Canada, this one is the 7th largest by enrollment of the 15 interventional ones that give a count, is the only one that started in 2017, is one of 3 with no phase, and was the 15th registered.
295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.
Browse Testicular Neoplasms studies →4 of the 21 studies in Testicular Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Western University, Canada · Sites in Canada
Ages 18+ · Men only
University Health Network, Toronto · Sites in Canada
Ages 18–40
University Health Network, Toronto · Sites in Canada
Ages 18+ · Men only
University of Southern California · Sites in Canada, United States
Ages 18+ · Men only
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 43 Testicular Neoplasms studies recruiting now, 26 (60%) set no upper age limit and 11 (26%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 144 is above the median of 50 across 190 interventional studies indexed under Testicular Neoplasms.
Median enrollment 138 across the 15 interventional studies, 230 across the 6 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
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1 of 21 have an industry lead sponsor. The 10 most frequent:
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
University Health Network, Toronto has 4 studies filed under Testicular Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Testicular Neoplasms with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03360994University Health Network, TorontoWATChmAN Virtual Testicular Cancer Clinic | 2026-12-01 |
| NCT04435756SWOG Cancer Research NetworkA Study of miRNA 371 in Patients With Germ Cell Tumors | 2027-01-01 |
| NCT07852871University Health Network, TorontomiRNA to Guide Appropriate Intervention of Small Testis Masses | 2027-02 |
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Among the 21 studies in Testicular Neoplasms with a site in Canada, from their registry updates:
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Princess Margaret's Multidisciplinary Testicular Cancer (TCa) Clinic sees over 25% of Ontario's testicular cancer patients, many of whom travel long distances. Fortunately, the majority of cases are confined to the testicle and are managed by "active surveillance" (AS), whereby blood work and imaging at regular intervals look to detect relapse at a curable stage. This currently requires multiple clinic visits over 5-9 years. This follow-up can be time-consuming, costly, difficult to adhere to and unsatisfying for patients. The goal of this project is to develop an efficient technological platform to perform virtual cancer follow-up. The platform has been named, "WATChmAN" which stands for Web-based virtual Testicular CANcer clinic. It will provide a secure, online interface to all virtual follow-up visits as an alternative to costly and time-consuming travel for in-person visits. The investigators anticipate improved patient satisfaction and dramatic reductions in the cost of cancer care follow-up. Moreover, the investigators anticipate improved compliance, which will lead to safer care. While TCa serves as the working platform, the investigators envision the end-product to be scalable and generalizable to other cancers (e.g. prostate cancer surveillance) across the province.
Patients randomized to the standard of care arm will be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. This involves blood marker and CT tests at predetermined intervals for 5-9 years depending on the patient's testicular cancer diagnosis (seminoma vs. non-seminoma). If randomized to this group, participants will be required to return to the Multidisciplinary Testicular Cancer Clinic to receive the results of their surveillance testing face-to-face in a medical appointment. In addition to these surveillance testing and follow-up visits, participants will also be asked to complete surveys regarding their satisfaction with the in-person active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins. As per current standard of care practice, participants may choose to have their imaging completed at a centre outside of the UHN. In these cases, participants will be required to obtain and send CDs with their imaging and reports to their most responsible oncologist at Princess Margaret. Blood marker visits can be performed anywhere without sending the results to Princess Margaret.
Patients randomized to the WATChmAN group will also be required to follow the active surveillance protocol created by the Multidisciplinary Testicular Cancer Clinic at Princess Margaret Hospital. If randomized to this group, a physician from the Multidisciplinary Testicular Cancer Clinic will still review the participant's surveillance testing results but will interact with the WATChmAN platform instead of receiving their results face-to-face in a medical appointment. Specifically, if randomized to this group participants will be required to:
Finally, in addition to these surveillance testing and WATChmAN interactions, participants will also be asked to complete surveys regarding their satisfaction with their virtual active surveillance program. These surveys will take approximately 10-15 minutes to complete and will be predominantly multiple choice. These surveys will be emailed to participants at 6 months, 1 year, 2 years and 5 years after the study begins.
It is predicted that the WATChmAN virtual platform will take at least one year to construct; however, the researchers involved in this study believe there is value in launching this virtual clinic without delay. This will also allow further improvements to the design of the WATChmAN platform as it is being built. Therefore, this study will be divided into two stages:
Stage I: During this stage, a clinical research coordinator alongside a nurse from the Genitourinary Clinic at the Princess Margaret Cancer Centre will manually perform all the anticipated functions of the WATChmAN platform. The clinical research coordinator will be responsible for all the administrative roles of WATChmAN including sending appointment reminders and scheduling follow-up virtual appointments. The nurse will be responsible for all the clinical functionalities of the WATChmAN platform. They will manually track patients' blood and imaging test results and work closely with the Multidisciplinary Testicular Cancer Clinic physicians to ensure that all patient surveillance results are reviewed. Patients randomized to the in-person AS group will receive the traditional standard of care which includes returning to clinic to meet with physicians face-to-face to receive imaging and blood testing results.
Stage II: During stage 2 of this investigation, the WATChmAN platform will be responsible for automatically populating the virtual clinic with blood and imaging results, sending appointment reminders and scheduling follow up appointments. The responsibilities of patients randomized to the WATChmAN group will be to acknowledge these email/text appointment reminders (i.e. yes/no to being aware of upcoming appointments), checking their results virtually and scheduling follow-up appointments through the WATChmAN platform. The research coordinator and nurse will continue to oversee the WATChmAN function but will not be manually collating surveillance results (markers/imaging etc.). Patients randomized to the in-person AS group receive the traditional standard of care, returning to the clinic to meet with a physician face-to-face to receive their surveillance imaging and blood marker results.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the WATChmAN Active Surveillance arm will receive their active surveillance testicular cancer care via an online virtual clinic. Importantly, patients will follow the same surveillance schedule as patients in the standard of care arm. However, patients in the WATChmAN arm will be able to see their upcoming tests and virtual appointments online, request requisitions to perform their required testing at outside institutions, and indicate any concerns for physicians to review during the virtual visit.
Other: WATChmAN Active Surveillance
Patients randomized to the standard of care arm (in-person active surveillance) will follow the current active surveillance protocol in place at Princess Margaret Cancer Centre's Multidisciplinary Testicular Cancer Clinic. This protocol involves the same schedule of testing as the WATChmAN arm, but will require patients to come into the clinic to receive their test results (as in current practice).
Other: In-person Active Surveillance
WATChmAN Active Surveillance uses an electronic tool used to provide active surveillance care to testicular cancer patients. This virtual active surveillance care is delivered with an identical schedule to in-person care without the need to come into clinic.
In-person active surveillance is the current recommended management option for all Stage I testicular cancer patients at Princess Margaret. Patients are monitored clinically with imaging and blood work, and active treatment only begins if relapse occurs.
Safety and Efficacy
Assess the safety and efficacy of administering active surveillance for testicular cancer on a virtual platform. Specifically, patient compliance, relapse incidence, extent of relapse, burden of treatment for relapse, modes of therapy required for relapse, and distal cancer outcomes.
Time frame: December 2017 - December 2026
Patient Satisfaction
Assess patient satisfaction with receiving their care virtually and with the system that administers the care.
Time frame: December 2017 - December 2026
Physician Satisfaction
Assess physician satisfaction with delivering care virtually and with the system that administers the care.
Time frame: December 2017 - December 2026
Clinic Flow Metrics
Assess how implementation of the WATChmAN virtual clinic has impacted the number of new patients seen in clinic, the CCO Wait 1 times (time from receipt of referral to first consult), physician estimations of time spent on follow-up, and examination of lost-to-follow-up rates.
Time frame: December 2017 - December 2026
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Dec 2026, 107 months after the start.
Of 31 interventional studies with no phase under Testicular Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 72. This study's planned 107 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →