Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
145 participants
OBSERVATIONAL
2022-11-30
2030-12-31
Brief Summary
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Detailed Description
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Efforts to improve the current standard of follow-up in patients with testicular cancer should focus on ameliorating quality of life and cost-effectiveness. It provides an opportunity to support patients emotionally, to evaluate treatment effects and complications, and to inform them on their individual prognosis. This is especially true considering the growing importance of value-based healthcare and patient reported outcomes in medicine. The investigators therefore propose a patient-led home-based follow-up approach. This follow-up strategy primarily consists of tumour marker level monitoring at home and imaging performed in-hospital, but additional counselling/diagnostic testing remains possible if desired by patients. In this way the investigators hope to meet the individual needs of patients during follow-up and to improve quality of life outcomes, while achieving equal or greater societal cost-effectiveness.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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D.J. (Dirk) Grünhagen
Principal Investigator
Principal Investigators
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Dirk J. Grünhagen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL78539.078.21
Identifier Type: -
Identifier Source: org_study_id
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