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

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Testicular Cancer

Treatments: Diagnostic Test: Skin biopsy; Diagnostic Test: Subcutaneous fat biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04113122

201700615

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Cross-sectional study:

Experimental group

Description:

Testicular cancer survivors who were treated between 2000 and 2005 or between 2006 and 2012 with cisplatin-combination chemotherapy and who were extensively phenotypically mapped within two longitudinal trials (15,16) will be invited to participate in a single cross-sectional follow-up study visit 5-20 years after chemotherapy.

Treatment:

Diagnostic Test: Subcutaneous fat biopsy

Diagnostic Test: Skin biopsy

Longitudinal study - chemotherapy group

Experimental group

Description:

Patients with metastasized testicular cancer who are about to start with cisplatin-combination chemotherapy will be invited in the longitudinal part of this study. Study participation involves four study visits: Visit 1: before start of chemotherapy Visit 2:before third cycle of chemotherapy Visit 3: one month after completion of chemotherapy Visit 4: one year after start of chemotherapy

Treatment:

Diagnostic Test: Subcutaneous fat biopsy

Diagnostic Test: Skin biopsy

Longitudinal study - stage I control group

Other group

Description:

Patients with stage I testicular cancer will serve as control group with three study visits: Visit 1: at time of orchidectomy Visit 2: one month Visit 3: one year after orchidectomy

Treatment:

Diagnostic Test: Subcutaneous fat biopsy

Diagnostic Test: Skin biopsy