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)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

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NCT05670938


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