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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
J. A. Gietema, prof.
j.a.gietema@umcg.nl
+31 50 361 2821
Time Frame
Start Date: 2019-02-09
Estimated Completion Date: 2026-09
Participants
Target number of participants: 192
Treatments
Experimental: Cross-sectional study:
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.
Experimental: Longitudinal study - chemotherapy group
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
Other: Longitudinal study - stage I control group
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
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen
Collaborators: Dutch Cancer Society

This content was sourced from clinicaltrials.gov