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NCT Number: NCT02890030

The Platinum Study Comparison Group

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.

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Key information

Conditions

Testicular Neoplasms Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Ear Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurotoxicity Syndromes Otorhinolaryngologic Diseases Ototoxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Radiation Injuries Testicular Diseases Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lawrence Einhorn

Other

Registry information

Official study title

Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2016
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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