Clinical trial NCT04113122: Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study
Official title: Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Testicular Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2019-10-02
Enrollment: 192
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A study will be performed consisting of two cohorts. Cross-sectional study Testicular cancer survivors treated between 2000 and 2005 or between 2006 and 2012 with cisplatin-combination chemotherapy and were extensively phenotypically mapped within two longitudinal trials will be invited to participate in a single cross-sectional follow-up study visit 5-20 years after chemotherapy.

Longitudinal study

Patients with metastasized testicular cancer who are about to start with cisplatin-combination chemotherapy will be invited. 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

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 after orchidectomy Visit 3: one year after orchidectomy
Primary purpose: PREVENTION

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)

Primary outcomes:
measure: Cellular senescence
timeFrame: 1 year
Secondary outcomes:
measure: Senescence-associated secretory phenotype (SASP)
timeFrame: 1 year
measure: Pulse-wave velocity
timeFrame: 1 year
measure: Platinum levels
timeFrame: 1 year
measure: Adipocytokines 1
timeFrame: 1 year
measure: Adipocytokines 2
timeFrame: 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: J. A. Gietema, Prof.
role: PRINCIPAL_INVESTIGATOR
References: