NCT04113122 Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study
| NCT ID | NCT04113122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Testicular Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2019-02-09 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2019-02-09 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cisplatin-combination chemotherapy causes inevitably DNA damage by platinum-DNA adduct formation of both tumor cells but also healthy cells. It therefore stands to reason that testicular cancer treatment causes an increased burden of senescent cells, which causes upregulation of the SASP resulting in a pro-inflammatory phenotype. The investigators hypothesize that this may be an important mechanism behind development of late effects and an early ageing phenotype after treatment for testicular cancer.
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in the cross-sectional part of this study, a subject must meet all of the following criteria: * Diagnosed with metastatic testicular cancer in 1999-2012 (stage II or higher) * Received first-line cisplatin-based chemotherapy * Was younger than 50 years of age at start of chemotherapy In order to be eligible to participate in the longitudinal part of this study, a subject must meet all of the following criteria: Chemotherapy-group: * Diagnosis of metastatic testicular cancer (stage II or higher) * Is about to start with first-line cisplatin-based chemotherapy * Younger than 50 years of age at diagnosis of metastatic testicular cancer Stage I control-group: * Diagnosis of testicular cancer stage I disease * Younger than 50 years of age at diagnosis of testicular cancer Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: \- Not able to provide informed consent (in example in case of mental or psychiatric disability)
Contact & Investigator
J. A. Gietema, Prof.
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT04113122 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Testicular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04113122 currently recruiting?
Yes, NCT04113122 is actively recruiting participants. Contact the research team at j.a.gietema@umcg.nl for enrollment information.
Where is the NCT04113122 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT04113122 clinical trial?
NCT04113122 is sponsored by University Medical Center Groningen. The principal investigator is J. A. Gietema, Prof. at University Medical Center Groningen. The trial plans to enroll 192 participants.
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