RecruitingNCT05670938
Follow-up After Surgery for Testicular Cancer
Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
Sponsor
Erasmus Medical Center
Enrollment
145 participants
Start Date
Nov 30, 2022
Study Type
OBSERVATIONAL
Conditions
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
Sex: MALEMin Age: 18 Years
Inclusion Criteria15
- Age ≥ 18 years.
- Histologically confirmed testicular cancer without distant metastasis and treated with curative intent less than 3 months ago:
- \. 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.
- \. 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.
- \. 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 Criteria4
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05670938
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