Testicular NeoplasmsNCT02890030
The Platinum Study Comparison Group
An observational study of Testicular Neoplasms, run by Lawrence Einhorn at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Testicular Neoplasms
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 14 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Patients with prior chemotherapy (whether for GCT or any other cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Testicular Neoplasms
- Being tested
- Questionnaire
- Keywords
- Cisplatin-based therapy, Ototoxicity, Neurotoxicity
- Medical subject headings
- Testicular Neoplasms, Ototoxicity, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
- Neurotoxicity
- Medications of interest
- General health
- Family history
| Study group | Role | What they receive |
|---|---|---|
| Case-Control | Patients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ototoxicity
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Measured: 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.
Measured: 1 year after surgery
Secondary outcomes (3)
Proportion of patients with obesity
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Measured: 1 year after surgery
Proportion of patients with hypertension
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Measured: 1 year after surgery
Proportion of patients who use antidepressants/anxiolytics
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2015
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Einhorn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lawrence Einhorn, Indiana University
- Investigators
- Lawrence Einhorn, MD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890030
- Sponsor's protocol ID
- IRB No. 1604502652
- Status last verified
- Apr 2020
- First submitted
- 8 Jun 2016
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
- ClinicalTrials.gov ID
- NCT02890030
- Acronym / sponsor ID
- IRB No. 1604502652
- Conditions
- Testicular Neoplasms
- Keywords
- Cisplatin-based therapy, Ototoxicity, Neurotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Lawrence EinhornUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case-Control | – | Behavioral: QuestionnairePatients with testicular germ cell tumor who were treated with surgery and not cisplatin-based chemotherapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with prior chemotherapy (whether for GCT or any other cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire* Neurotoxicity * Medications of interest * General health * Family history | Behavioural | Case-Control |
Primary outcome
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.
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.
3 secondary outcomes
Proportion of patients with obesity
Time frame: 1 year after surgery
Proportion of patients with hypertension
Time frame: 1 year after surgery
Proportion of patients who use antidepressants/anxiolytics
Time frame: 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Einhorn, MD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Neoplasms, run by Lawrence Einhorn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with ototoxicity (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.