Follow-up After Surgery for Testicular Cancer

Recruiting now

Conditions studied: Testicular Cancer, Testicular Germ Cell Tumor, Quality of Life

In brief

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.

Key facts

Study ID

NCT05670938

Run by

Erasmus Medical Center

People needed

145

Starts

2022-11-30

Expected to finish

2030-12-01

Last updated by the study team

2023-02-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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