Follow-up after treatment for testicular cancer: the prospective, single centre FUTURE-testis implementation study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 145

Inclusion Criteria

• Age >= 18 years.
• Histologically confirmed testicular cancer without distant metastasis and
treated with curative intent less than 6 months ago:
o 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.
o Non-seminomatous germ cell tumours, stage I high risk, and combined tumors:
* 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.
o 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 with a severely complicated postoperative course, needing in hospital
follow-up longer than 6 months postoperatively • 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is the successful implementation of<br /><br>home-based tumor marker measurements with a lancing kit. Successful<br /><br>implementation of the home-based aspect is defined as 25% or more of all tumor<br /><br>marker measurements actually being performed at home by the patients<br /><br>themselves. The idea is that if less than 25% of possible home-based<br /><br>measurements are utilized, the added value of giving the patient the choice to<br /><br>perform home-based measurements is minimal. </p><br>

Secondary Outcome Measures