Testicular CancerFUTURE-testisNCT05670938
Follow-up After Surgery for Testicular Cancer
An observational study of Testicular Cancer and Testicular Germ Cell Tumor, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer, Testicular Germ Cell Tumor, Quality of Life
- How many people
- 145 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Nov 2022to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Lissa Wullaert, +316107042125, l.wullaert@erasmusmc.nl
Kelly R. Voigt, +316107042125, k.voigt@erasmusmc.nl
About this study
Official title: Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
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.
Read the detailed description
Testicular cancer represents 1% of male neoplasms and 5% of all urological tumours. In 2021, 828 new patients in the Netherlands were diagnosed with testicular cancer. It is the most commonly diagnosed cancer among young men aged 20-39 years in the Netherlands and incidence is rising. Follow-up after treatment of testicular cancer consists of tumour marker assessment during hospital visits and multiple types of imaging at certain time points. Frequent hospital visits have significant impact on patients' lives, as in-hospital visits evoke distress around the time of visits. Home-based follow-up could be beneficial in terms of patients' well-being and societal cost-effectiveness. Furthermore, during the COVID-19 pandemic hospital visitations are minimized to decrease the chance of COVID-19 exposure. Home-based blood sampling will allow patients to stay home and avoid crowded areas such as public transport and the hospital.
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.
- Keywords
- Follow-up
- Medical subject headings
- Testicular Neoplasms, Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful implementation
Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.
Measured: Year 8 (after the last follow-up moment of the last included patient)
Secondary outcomes (9)
Successful home-based sampling
Defined as 25% or more of all scheduled or optional tumour marker assessments actually performed in blood collected by the patients themselves using the self-administered blood-sampling kit
Measured: Year 8
Quality of life of testicular cancer patients
Measured by the EORTC Core Quality of Life questionnaire (QLQ-C30). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.
Measured: Year 8
Health-related quality of life
Measured by the EORTC Quality of Life Questionnaire - Testicular Cancer Module (EORTC QLQ-TC26). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.
Measured: Year 8
Momentary quality of life
Measured by ecological momentary assessment using the Global health status of the EORTC QLQ-C30. The 2 items are scored on a Likert-scale from 1 to 7. Higher scores mean a better outcome.
Measured: Year 8
Anxiety
Measured by The State-Trait Anxiety Inventory: Six-Item Short-form (STAI-6). The STAI-6 comprises of 6 items, each scored on a Likert-scale from 1-4. The final score ranges from 20-80 and is calculated by adding up the score of all single items (positive items are reverse scored) and multiplying by 20/6. Higher scores mean a better outcome.
Measured: Year 8
Fear of cancer recurrence
Measured by the Assessment of Survivor Concerns - Cancer Worry subscale (ASC-CW). The total score is calculated by adding up the individual items and ranges from 3-12. Higher scores mean a worse outcome.
Measured: Year 8
Cost-effectiveness of a patient-led home-based follow-up
The primary effect measure for the economic evaluation will be quality of life, using the The European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) as a basis for measuring utility. The EQ-5D-5L consists of five levels (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each scored on a Likert-scale from 1-5 and a visual analogue scale (VAS) scored from 0-100. The total score can be converted into an index value to be used in QALY analysis by ways of an index value calculator taking into account country-specific reference values.
Measured: Year 8
Relation between coping style and follow-up preferences
Measured by the Threatening Medical Situations Inventory (TMSI). Total monitoring and blunting scores are obtained by summing up the relevant items, ranging from 12-60.
Measured: Year 8
Satisfaction of the patient-led home-based follow-up
By a two-item questionnaire at the last follow-up. The first question about satisfaction consists of a scale from 1 to 10. Higher score means a better outcome. The second question is an open question whether the patient has ideas to improve the follow-up.
Measured: Year 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start30 Nov 2022
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.J. (Dirk) Grünhagen, Erasmus Medical Center
- Investigators
- Dirk J. Grünhagen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670938
- Sponsor's protocol ID
- NL78539.078.21
- Acronym
- FUTURE-testis
- Status last verified
- Feb 2023
- First submitted
- 2 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
- ClinicalTrials.gov ID
- NCT05670938
- Acronym / sponsor ID
- FUTURE-testis / NL78539.078.21
- Keywords
- Follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Testicular cancer represents 1% of male neoplasms and 5% of all urological tumours. In 2021, 828 new patients in the Netherlands were diagnosed with testicular cancer. It is the most commonly diagnosed cancer among young men aged 20-39 years in the Netherlands and incidence is rising. Follow-up after treatment of testicular cancer consists of tumour marker assessment during hospital visits and multiple types of imaging at certain time points. Frequent hospital visits have significant impact on patients' lives, as in-hospital visits evoke distress around the time of visits. Home-based follow-up could be beneficial in terms of patients' well-being and societal cost-effectiveness. Furthermore, during the COVID-19 pandemic hospital visitations are minimized to decrease the chance of COVID-19 exposure. Home-based blood sampling will allow patients to stay home and avoid crowded areas such as public transport and the hospital.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- Age ≥ 18 years.
- Histologically confirmed testicular cancer without distant metastasis and treated with curative intent less than 3 months ago:
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful implementation
Time frame: Year 8 (after the last follow-up moment of the last included patient)
Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.
9 secondary outcomes
Successful home-based sampling
Time frame: Year 8
Quality of life of testicular cancer patients
Time frame: Year 8
Health-related quality of life
Time frame: Year 8
Momentary quality of life
Time frame: Year 8
Anxiety
Time frame: Year 8
Fear of cancer recurrence
Time frame: Year 8
Cost-effectiveness of a patient-led home-based follow-up
Time frame: Year 8
Relation between coping style and follow-up preferences
Time frame: Year 8
Satisfaction of the patient-led home-based follow-up
Time frame: Year 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk J. Grünhagen, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer and Testicular Germ Cell Tumor, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lissa Wullaert, MD (+316107042125, l.wullaert@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful implementation (time frame: Year 8 (after the last follow-up moment of the last included patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.