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Search / Trial NCT05670938

Follow-up After Surgery for Testicular Cancer

Launched by ERASMUS MEDICAL CENTER · Jan 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Follow Up

ClinConnect Summary

This clinical trial is looking at a new way to follow up with men who have been treated for certain types of testicular cancer. Instead of traditional hospital visits, the study will see if a patient-led home-based follow-up can help improve quality of life, reduce anxiety, and lessen fears about cancer coming back after treatment. The trial is currently recruiting men aged 18 and older who have recently completed treatment for testicular cancer and meet specific health criteria, such as having normal blood test results after treatment.

Participants in this study will take part in follow-up care from home, which may include filling out questionnaires about their health and feelings. This approach aims to make patients feel more in control of their recovery while still getting the support they need. It's important to note that individuals with certain health issues or those participating in other studies may not be eligible to join. Overall, this trial is a chance for patients to engage in their follow-up care in a more personal and potentially less stressful way.

Gender

MALE

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

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Rotterdam, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Dirk J. Grünhagen, MD, PhD

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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