Home-based follow-up for testicular cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates a patient-led home-based follow-up approach for individuals treated for testicular cancer. It aims to assess whether this method improves quality of life, reduces anxiety, and lessens fear of cancer recurrence compared to traditional hospital visits. The study focuses on patients who have undergone treatment for testicular cancer within the last three months and will utilize home-based blood sampling to minimize hospital visits and associated distress. The approach is particularly relevant in light of the COVID-19 pandemic, which has limited in-person hospital visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Dirk J. Grünhagen, MD, PhD — Erasmus Medical Center
• Study coordinator: Lissa Wullaert, MD
• Email: l.wullaert@erasmusmc.nl
• Phone: +316107042125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.