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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center

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
Case-Control
Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy
Behavioral: Questionnaire
  • Neurotoxicity
  • Medications of interest
  • General health
  • Family history

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

Lawrence Einhorn

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

Keywords

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.

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