Actively Recruiting
Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
Led by Erasmus Medical Center · Updated on 2023-02-23
145
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Testicular cancer affects mainly young men and represents a small percentage of male cancers and urological tumors. This research evaluates a patient-led home-based follow-up method after testicular cancer treatment, aiming to improve quality of life, reduce anxiety, and lessen fear of cancer returning. The study addresses the impact of frequent hospital visits and seeks to find a less distressing and more cost-effective follow-up approach. The follow-up approach studied primarily involves patients monitoring tumor marker levels at home through blood sampling, while imaging continues to be done in hospitals. Additional counseling or diagnostic tests are available as needed. The study includes different patient groups based on tumor type and treatment received, with all participants monitored after surgery or chemotherapy and confirmed remission. Participants will be involved in home blood sampling and hospital imaging at scheduled times, with ongoing assessments of quality of life, anxiety, and fear of recurrence. Researchers will track successful implementation, patient satisfaction, and cost-effectiveness over eight years after the last patient completes follow-up. The study also explores coping styles and their relation to follow-up preferences.
CONDITIONS
Brief Title
Follow-up After Surgery for Testicular Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically confirmed testicular cancer without distant metastasis treated with curative intent less than 3 months ago
- Non-seminomatous germ cell tumours, stage I low risk with no lymphadenopathy or metastases on postoperative scan
- Three consecutive blood tests with normal tumour markers
- Patients with lymph node dissection after orchiectomy if no residual disease or metastases on postoperative scan
- Non-seminomatous germ cell tumours, stage I high risk after one cycle of BEP chemotherapy
- Biochemical remission after chemotherapy with three consecutive normal tumour marker tests
- No lymphadenopathy or metastases on CT scan after chemotherapy
- Seminomatous or non-seminomatous germ cell tumours after chemotherapy with complete remission
- Scheduled or currently undergoing postoperative surveillance following guidelines
- Signed informed consent
You will not qualify if you...
- Aberrant levels of LDH preoperatively (greater than 248 U/L)
- Enrolled in other studies requiring strict follow-up with yearly or more frequent imaging of abdomen or thorax
- Comorbidity or other malignancy requiring yearly or more frequent imaging of abdomen or thorax
- Inability to complete questionnaires due to illiteracy or insufficient proficiency in Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 years
Participants are monitored with home-based blood sampling for tumour marker levels and imaging performed in-hospital at specific time points as part of their post-surgery follow-up.
Regular home-based blood sampling and scheduled in-hospital imaging visits
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
L
Lissa Wullaert, MD
K
Kelly R. Voigt, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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