Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin biopsy, Subcutaneous fat biopsy.
- Who it may be relevant to
- Registry conditions: Testicular Cancer. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Skin biopsy
A 4 mm skin biopsy will be performed at the upper leg of the patient. Before the skin biopsy local anesthesia is applied subcutaneously. In these skin biopsies senescent cells will be detected by p16, p21 and yH2Ax staining. Furthermore, we will measure platinum levels in the skin biopsies. - Diagnostic test Subcutaneous fat biopsy
An abdominal subcutaneous fat biopsy will be performed 7-10 cm on the right side of the umbilicus. Before the fat biopsy local anesthesia is applied subcutaneously. An amount of 30 mg fat tissue will be collected using needle aspiration. In these fat biopsies senescent cells will be detected by p16, p21 and yH2Ax staining. Furthermore, we will measure platinum levels (ICP-MS), adipocytokines (leptin, adiponectin, interleukin-6, PAI-1, TNF-α), p53 activation indirectly by measuring p21 or mdm2 e
Primary outcome measures
- Cellular senescence [Time frame: 1 year]
Secondary outcome measures (5)
- Senescence-associated secretory phenotype (SASP) [Time frame: 1 year]
- Pulse-wave velocity [Time frame: 1 year]
- Platinum levels [Time frame: 1 year]
- Adipocytokines 1 [Time frame: 1 year]
- Adipocytokines 2 [Time frame: 1 year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT04113122 · 201700615