NCT05670938 Follow-up After Surgery for Testicular Cancer
| NCT ID | NCT05670938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Testicular Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 145 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 145 participants in total. It began in 2022-11-30 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after treatment of certain types of testicular cancer.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed testicular cancer without distant metastasis and treated with curative intent less than 3 months ago: 1\. Non-seminomatous germ cell tumours, stage I low risk: * No lymphadenopathy or metastases on the postoperative scan. * Three consecutive blood drawings with normal tumour markers. * Patients undergoing lymph node dissection as a second curative operation after an orchiectomy, can also be included in case that the postoperative scan shows no residual disease or metastases. 2\. Non-seminomatous germ cell tumours, stage I high risk: * After completion of one cycle of Bleomycin, etoposide and platinum (BEP). * Biochemical remission at completion of chemotherapy, meaning three consecutive blood drawings with normal tumour markers. * No lymphadenopathy or metastases on the CT scan after completion of chemotherapy. 3\. Seminomatous or non-seminomatous germ cell tumours (after chemotherapy) with complete remission. * Biochemical remission at completion of chemotherapy, meaning three consecutive blood drawings with normal tumour markers. * No lymphadenopathy or metastases on the CT scan after completion of chemotherapy. * Scheduled or currently undergoing postoperative surveillance according to national and European guidelines. * Signed informed consent. Exclusion Criteria: * Patients with aberrant levels of LDH preoperatively (LDH \>248 U/L). * Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax * Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent * Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
Contact & Investigator
Dirk J. Grünhagen, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT05670938 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Testicular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05670938 currently recruiting?
Yes, NCT05670938 is actively recruiting participants. Contact the research team at l.wullaert@erasmusmc.nl for enrollment information.
Where is the NCT05670938 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05670938 clinical trial?
NCT05670938 is sponsored by Erasmus Medical Center. The principal investigator is Dirk J. Grünhagen, MD, PhD at Erasmus Medical Center. The trial plans to enroll 145 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.