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Senescence and the early ageing phenotype after chemotherapy for testicular cancer: the SEA-CAT study

Senescence and the early ageing phenotype after chemotherapy for testicular cancer: the SEA-CAT study - SEA-CAT study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52734
Enrollment
192
Registered
2018-08-31
Start date
2019-02-09
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cross-sectional part of this study: - Diagnosed with metastatic testicular cancer in 1999-2019 and participated in the above mentioned longitudinal studies (stage II or higher) - Received first-line cisplatin-based chemotherapy - Was younger than 50 years of age at start of chemotherapy, Longitudinal part of this study: 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 In order to be eligible to participate in the control group of this study, a subject must meet all of the following criteria: Healthy control-group: - Male younger than 60 years of age

Exclusion criteria

Exclusion criteria: - Earlier diagnosis with another malignancy except from successfully treated squamous cell carcinoma of the skin. - Not able to provide informed consent (in example in case of mental or psychiatric disability)

Design outcomes

Primary

MeasureTime frame
In the cross-sectional part of this study the primary endpoint is correlation between senescence and the early ageing phenotype. The amount of senescent cells in skin and fat tissue will be correlated with the early ageing phenotype defined as a) vascular stiffness (pulse wave velocity, PWV), the gold standard measurement for vascular age and b) the metabolic syndrome. In the longitudinal part of the study the primary endpoint will be to investigate the development of senescent burden during cisplatin-combination chemotherapy. The percentage, and -if any- upregulation of senescent cells in skin and fat tissue will be measured and compared between pre-chemotherapy measurements and the different time points afterwards and compared between the chemotherapy group, the stage I control group and the healthy control group.

Secondary

MeasureTime frame
- Senescence-associated secretory phenotype (SASP): Defined as elevated levels of the cytokines IL-6, IL-8 or VEGF. - (Sub)clinical features of the early ageing phenotype: Presence or development of the early ageing phenotype will be assessed measuring vascular damage (vascular stiffness (pulse-wave velocity, PWV), biomarkers, intima-media thickness (IMT), peripheral digital ischaemia, systolic and diastolic cardiac function, global longitudinal strain (GLS), and advanced glycation end products (AGEs) as measure for metabolic memory). Presence or development of cardiovascular risk factors will be assessed (body mass index, waist-hip ratio, blood pressure, lipid profile, fasting glucose and presence of the metabolic syndrome. - Platinum levels: Both circulating platinum levels and the amount of platinum depositions in skin and fat tissue will be assessed (ICP-MS). - Fat tissue metabolism and metabolic state: The adipocytokines (leptin, adiponectin, IL-6, PAI-1, TNF-a), p53 activation and microRNA regulation of insulin signaling in adipose tissue: miR-103, miR-107, miR-29) will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)