The Platinum Study Comparison Group

NCT02890030 | Completed DMC

• 1 other identifier: IRB No. 1604502652
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Neoplasms

Keywords

Cisplatin-based therapy; Ototoxicity; Neurotoxicity

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with ototoxicity

  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

  The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.

  1 year after surgery

Secondary Outcomes (3)

• Proportion of patients with obesity

  1 year after surgery

• Proportion of patients with hypertension

  1 year after surgery

• Proportion of patients who use antidepressants/anxiolytics

  1 year after surgery

Study Arms (1)

Case-Control

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

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

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

Case-Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with prior chemotherapy (whether for GCT or any other cancer)

Sponsors & Collaborators

• Lawrence Einhorn: lead

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Ototoxicity; Neurotoxicity Syndromes

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lawrence Einhorn, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor of Medicine

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: September 7, 2016
• Study Start: May 1, 2015
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)