The Platinum Study Comparison Group

Study Overview
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Brief Summary
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The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy.

Detailed Description
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Primary Objective To compare the prevalence of ototoxicity and neurotoxicity in GCT cancer survivors who only had surgery to a similar population from The Platinum Study (RSRB45410/1305011509) who received cisplatin-based combination chemotherapy. Secondary Objective To compare the prevalence of obesity, hypertension, and use of antidepressants/anxiolytics in GCT cancer survivors who only had surgery to a similar population from The Platinum Study who received cisplatin-based combination chemotherapy.

Official Title
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Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study

Conditions
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Testicular Neoplasms

Intervention / Treatment
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* Behavioral: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis or confirmation of diagnosis of a histologically or serologically confirmed testicular germ cell tumor (GCT) or GCT at another anatomic location Age at GCT diagnosis: 55 years of age or younger Males, 18 years of age or older at time of study consent Subject is able to provide consent Subject is able to speak and read English Treatment consisted of surgery only (i.e., orchiectomy and/or retroperitoneal lymph node dissection [RPLND]) for either initial testicular germ cell tumor (GCT) or subsequent testicular cancer Subject completed surgery > 1 year ago Subject is currently undergoing active follow-up at IU Subject did not require any subsequent chemotherapy, salvage chemotherapy treatment or bone marrow transplant. Subject had no prior chemotherapy of any kind Exclusion Criteria: Patients with prior chemotherapy (whether for GCT or any other cancer)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case-Control<br>Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy | Behavioral: Questionnaire<br>* Neurotoxicity Medications of interest General health Family history<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ototoxicity | The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study. | 1 year after surgery | 
| Proportion of patients with neurotoxicity | The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with obesity | The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study. | 1 year after surgery | 
| Proportion of patients with hypertension | The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study. | 1 year after surgery | 
| Proportion of patients who use antidepressants/anxiolytics | The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study. | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisplatin-based therapy, Ototoxicity, Neurotoxicity