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The Platinum Study Comparison Group

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890030
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Lawrence Einhorn, Indiana University School of Medicine

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.

Condition or disease Intervention/treatment
Testicular Neoplasms Behavioral: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
Study Start Date : May 2015
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890030


Locations
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United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Lawrence Einhorn
Investigators
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Principal Investigator: Lawrence Einhorn, MD Indiana University School of Medicine, Indiana University Simon Cancer Center
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Responsible Party: Lawrence Einhorn, Distinguished Professor of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02890030    
Other Study ID Numbers: IRB No. 1604502652
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Keywords provided by Lawrence Einhorn, Indiana University School of Medicine:
Cisplatin-based therapy
Ototoxicity
Neurotoxicity
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders