Study Stopped
Lack of funding
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy
1 other identifier
observational
N/A
1 country
1
Brief Summary
This study targets patients with cisplatin-induced peripheral neuropathy and will allow us to: a) study peripheral neuropathy in diverse human sensory neurons in ways that were not possible previously; b) gain insight on druggable targets to treat or prevent this devastating side effect of chemotherapy; c) provide a human cellular model that can be used for screening of drugs to determine if they are neurotoxic. The combination of patient information and in vitro measurements provides a highly relevant and clinically useful model for studies aimed to impact treatment selection for the individual cancer patient.
Trial Health
Trial Health Score
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Started Dec 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 28, 2018
February 1, 2018
2 years
May 13, 2015
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biobank of peripheral blood mononuclear cells (PBMCs)
PBMCs will be used for the future creation of iPS cells with the potential to make human neurons
Once (at enrollment)
Study Arms (2)
Severe Toxicity Group
Diagnosis of testicular cancer; History of any grade 3 or higher peripheral neuropathy after receiving standard dose cisplatin completed more than 1 year but within the last 5 years; Long-term persistence (\> 6 months) of grade 2 or higher peripheral neuropathy after completion of a cisplatin containing regimen. Interventions: blood sample collection and report of peripheral neuropathy after cisplatin therapy.
Control Group
Diagnosis of testicular cancer; No history of neurotoxicity (grade 0-1) after completion of a standard cisplatin-containing chemotherapy regimen completed more than 1 year but within the last 5 years; Matched to a specified subject with neurotoxicity based on age (within 10 years), chemotherapy regimen or total cisplatin dosage. Interventions: blood sample collection and report of peripheral neuropathy after cisplatin therapy.
Interventions
Six tubes of blood will be collected during one blood draw.
Twenty questions about the peripheral neuropathy the patient is currently experiencing, and twenty questions about the worst peripheral neuropathy the patient ever experienced after cisplatin treatment.
Eligibility Criteria
This study will consist of two groups: testicular cancer patients with severe neuropathy (experimental group) and testicular cancer patients without neuropathy (control group). One control subject will be recruited for each experimental subject with severe neurotoxicity. Controls will be matched based on age (within 10 years), tumor type, race, ethnicity, and chemotherapy regimen and cumulative dose of cisplatin during which the toxicity occurred.
You may qualify if:
- Diagnosis of testicular cancer
- Age ≥ 18 years at the time of informed consent
- Male
- History of any grade 3 or higher peripheral neuropathy after receiving standard dose cisplatin completed more than 1 year but within the last 5 years
- Long-term persistence (\> 6 months) of grade 2 or higher peripheral neuropathy after completion of a cisplatin containing regimen.
- Patient understands the nature of the study and provides written informed consent
- Diagnosis of testicular cancer
- Age ≥ 18 years
- Male
- No history of neurotoxicity (grade 0-1) after completion of a standard cisplatin-containing chemotherapy regimen completed more than 1 year but within the last 5 years
- Matched to a specified subject with neurotoxicity based on age (within 10 years), chemotherapy regimen or total cisplatin dosage
- Patient understands the nature of the study and provides informed consent
You may not qualify if:
- Treatment with other severely neurotoxic chemotherapy prior to or concomitantly with cisplatin.
- Presence of peripheral neuropathy prior to cisplatin therapy
- Poorly controlled or insulin-dependent diabetes or other conditions likely to predispose neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Biospecimen
Whole blood samples will be obtained from all patients so that peripheral blood mononuclear cells (PBMCs) can be isolated and stored for the eventual creation of iPS cells. iPS cells have the potential to make human neurons that the researchers would like to use for functional studies of specific genes/genetic variants. All samples will also be tested for infectious diseases (Hepatitis B, Hepatitis C, HIV 1 and HIV 2).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Costantine Albany, MD
Indiana University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Faculty
Study Record Dates
First Submitted
May 13, 2015
First Posted
July 8, 2015
Study Start
December 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 28, 2018
Record last verified: 2018-02