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NCT Number: NCT04113122

Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study

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.

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Key information

Conditions

Testicular Cancer Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location status: Recruiting

Location contact

J. A. Gietema, Prof.

CONTACT

[email protected]

+31 50 361 2821

J. A. Gietema, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skin Biopsy

Diagnostic Test

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.

Subcutaneous fat biopsy

Diagnostic Test

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 expression using immunohistochemistry, microRNA regulation of insulin signaling in adipose tissue: miR-103, miR-107, miR-29.

Primary outcomes

  1. Cellular senescence

    Time frame: 1 year

    The change in the amount of senescent cells in skin and fat tissue (defined as % of cells in which nucleus is stained positive for P16, P21 and yH2Ax)

Secondary outcomes

  1. Senescence-associated secretory phenotype (SASP)

    Time frame: 1 year

    Change in levels of the cytokines: IL-6, IL-8, VEGF

  2. Pulse-wave velocity

    Time frame: 1 year

    Presence or development of the early ageing phenotype will be assessed measuring vascular damage: change in vascular stiffness (pulse-wave velocity, PWV).

  3. Platinum levels

    Time frame: 1 year

    Changes in circulating platinum levels and the amount of platinum depositions in skin and fat tissure will be assessed.

  4. Adipocytokines 1

    Time frame: 1 year

    Changes in levels of leptin and PAI-1 (ug/L)

  5. Adipocytokines 2

    Time frame: 1 year

    Changes in levels of adiponectin (ug/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

J. A. Gietema, prof.

CONTACT

[email protected]

+31 50 361 2821

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Dutch Cancer Society

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2019
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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