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Active, not recruitingNCT01783145SCFU-TCUpdated May 25, 2025

Shared Care Follow-up After Chemotherapy for Testicular Cancer

An observational study in Testicular Cancer, sponsored by University Medical Center Groningen. Active, not recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by University Medical Center Groningen · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
163
Ages
18 Years and older
Sex
Male
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Study summary

The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Read the detailed description

Rationale: Since the introduction of cisplatin, metastatic testicular cancer (TC) has become a highly curable disease. Successfully treated TC patients have a small chance of a relapse. In case of a relapse, early treatment will improve outcome. This stresses the need for a frequent and stringent follow-up scheme. Although chemotherapy is a very effective treatment, a downside of this treatment has now become apparent: chemotherapy-related complications such as the increased risk for cardiovascular disease (CVD) and secondary malignancies. CVD can manifest during treatment, but also years or decades thereafter. We recently observed early development of cardiovascular risk factors in TC patients, clustered into the metabolic syndrome. Monitoring and treatment of cardiovascular risk factors during follow-up is important to lower the chance of developing CVD.

Since TC survivors are discharged from follow-up after 10 years, collaboration between oncologists and general practitioners (GPs), in other words shared care, will ensure monitoring of cardiovascular risk factors and timely detection and treatment of late effects (cardiovascular risk management). Survivorship care plans for cancer survivors, GPs and oncologists facilitate care for long-term survivors. The testicular cancer survivor himself is the key person, who can be empowered to participate in follow-up programs and make lifestyle adjustments to decrease the risk of late effects and improve quality of life and life expectancy. However, data are scarce on the design of an evidence based effective follow-up schedule. For childhood cancer survivors a detailed guideline has been developed that can serve as a framework for adult cancer survivor follow-up.

Objective: To examine the safety and feasibility of a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Study population: Patients that achieved a complete remission after chemotherapy for metastatic testicular cancer who are starting with follow-up or are currently in active follow-up.

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Conditions studied

  • Testicular Cancer

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Keywords

  • survivorship care
  • testicular cancer
  • shared care model
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In context

Testicular Neoplasms

189 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.

This study's enrollment of 163 is above the median of 145 across 61 observational studies indexed under Testicular Neoplasms.

Browse Testicular Neoplasms studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

Inclusion criteria

  • Patients with disseminated testicular cancer;
  • Complete remission after chemotherapy with or without adjunctive surgery and in active follow-up;
  • Age 18 years or older;
  • Started with chemotherapy after January 1st 2003;
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

•Mental disability

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
163 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients

    Patients with disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

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What researchers measure

Primary outcomes

  1. Safety of a shared care survivorship care plan (SCP).

    The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.

    Time frame: Monitoring of safety will be done on a continuous basis with average duration of two years per participant.

  2. Feasibility of a shared care survivorship care plan (SCP).

    The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.

    Time frame: Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.

Secondary outcomes

  1. Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.

    The satisfaction with the SCP of testicular cancer survivors, GPs and oncologists will be evaluated by using questionnaires.

    Time frame: Up to two years.

  2. Willingness to migrate from hospital care to primary care.

    The willingness to migrate from hospital care to primary care will be evaluated by specifying the decisions made within the SCP and by questionnaires to patients and GPs.

    Time frame: Up to two years.

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01783145
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Feb 4, 2013
Start date
Oct 2012
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
May 25, 2025

Study contacts

J.A. Gietema, MD, PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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