Follow-up After Surgery for Testicular Cancer
FUTURE-testis
1 other identifier
observational
145
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2022
CompletedFirst Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
February 23, 2023
February 1, 2023
8 years
January 2, 2023
February 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful implementation
Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.
Year 8 (after the last follow-up moment of the last included patient)
Secondary Outcomes (9)
Successful home-based sampling
Year 8
Quality of life of testicular cancer patients
Year 8
Health-related quality of life
Year 8
Momentary quality of life
Year 8
Anxiety
Year 8
- +4 more secondary outcomes
Study Arms (4)
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 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.
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.
Eligibility Criteria
Patients who are 18 years or older who received curative intent surgical treatment for testicular cancer, and who (will) undergo postoperative surveillance are eligible. Patients can be included up to 3 months after curative treatment.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medical Center
Rotterdam, South Holland, 3015GD, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk J. Grünhagen, MD, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
November 30, 2022
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
February 23, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share