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Follow-up After Surgery for Testicular Cancer
RECRUITINGSponsored by Erasmus Medical Center
Actively Recruiting
SponsorErasmus Medical Center
Started2022-11-30
Est. completion2030-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05670938
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
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
Conditions4
CancerQuality of LifeTesticular CancerTesticular Germ Cell Tumor
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Actively Recruiting
SponsorErasmus Medical Center
Started2022-11-30
Est. completion2030-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05670938