The Platinum Study Comparison Group

NCT ID: NCT02890030

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-06-14

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.

Conditions

Testicular Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case-Control

Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy

Questionnaire

Intervention Type: BEHAVIORAL

• Neurotoxicity
• Medications of interest
• General health
• Family history

Interventions

Questionnaire

• Neurotoxicity
• Medications of interest
• General health
• Family history

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lawrence Einhorn

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Einhorn

Distinguished Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lawrence Einhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine, Indiana University Simon Cancer Center

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IRB No. 1604502652

Identifier Type: -

Identifier Source: org_study_id