The Platinum Study Comparison Group
April 7, 2020 updated by: Lawrence Einhorn
Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Case-Control
Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with ototoxicity
Time Frame: 1 year after surgery
|
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
Time Frame: 1 year after surgery
|
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
Time Frame: 1 year after surgery
|
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
Time Frame: 1 year after surgery
|
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
Time Frame: 1 year after surgery
|
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
|
1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lawrence Einhorn, MD, Indiana University School of Medicine, Indiana University Simon Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
June 14, 2017
Study Completion (Actual)
June 14, 2017
Study Registration Dates
First Submitted
June 8, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
April 7, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB No. 1604502652
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.