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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case-Control | Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients with testicular germ cell tumor diagnosis at the age of 18-55 who were treated with surgery only and not chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Einhorn, MD | Indiana University School of Medicine, Indiana University Simon Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D000081015 | Ototoxicity |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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 |
| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |