Clinical trial NCT02890030: The Platinum Study Comparison Group
Official title: Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Neoplasms
Keywords: Cisplatin-based therapy
Ototoxicity
Neurotoxicity
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with testicular germ cell tumor diagnosis at the age of 18-55 who were treated with surgery only and not chemotherapy.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients with ototoxicity
timeFrame: 1 year after surgery
measure: Proportion of patients with neurotoxicity
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Proportion of patients with obesity
timeFrame: 1 year after surgery
measure: Proportion of patients with hypertension
timeFrame: 1 year after surgery
measure: Proportion of patients who use antidepressants/anxiolytics
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Indiana University Simon Cancer Center
name: Lawrence Einhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: