Peripheral Nervous System DiseasesNCT02492360
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy
An observational study of Peripheral Nervous System Diseases and Testicular Neoplasms, run by Costantine Albany at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peripheral Nervous System Diseases, Testicular Neoplasms
- What is being tested?
- Blood sample collection and Report of peripheral neuropathy after cisplatin therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2017to Dec 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary Objective-To establish a biobank of specimens that allows for the future creation of iPS cells with the potential to make human neurons for functional studies of specific genes/genetic variants.
Secondary Objectives-To develop a clinically relevant in vitro model of cisplatin induced peripheral neuropathy to be used to 1) screen new drugs for the treatment or prevention of peripheral neuropathy; 2) evaluate candidate genes for their role in cisplatin induced neuropathy.
Study Procedures-Subjects who wish to participate will undergo the following study procedures, which will be performed after the informed consent document is obtained:
- Sample Collection-A trained phlebotomist will conduct a blood draw for the collection of SIX samples for peripheral blood mononuclear cell (PBMC) isolation and infectious disease testing.
- Patient Self-Report of Toxicities-All patients in the study will be asked to fill out the Patient-reported Toxicity Form. This will take approximately 10 minutes to complete and consists of 20 questions related to patient symptoms describing toxicities experienced secondary to receiving cisplatin chemotherapy. They will be asked to fill out the form twice: (1) describing the peripheral neuropathy they currently are experiencing and (2) describing the worst peripheral neuropathy toxicity they experienced as a result of cisplatin therapy. These paper forms will be filled out at time of enrollment in the study.
- Physician Report of Toxicities-The patient's physician or the designatee will complete an adverse event form at day of enrollment detailing the physician's assigned grade of toxicities (according to CTCAE version 4.3) experienced from cisplatin. Other information regarding the particularly severe neurotoxicity may also be collected from physicians (e.g. patient use of walker or wheelchair, patient application for disability based on neuropathy).
- General Information- This information will be collected at the same time point as all of the other study procedures (i.e., Day One). This will include but may not be limited to: age, height, weight, patient-identified race and ethnicity, information about the chemotherapy regimen, total cisplatin dose administered and date of last cisplatin dose.
- Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded. Outside records will be obtained where needed.
- Follow-up and Duration of Follow-Up-There will be no subsequent patient follow-up after time of enrollment. Subjects may withdraw consent for specimen use by contacting the PI in writing.
- Being tested
- Blood sample collection, Report of peripheral neuropathy after cisplatin therapy
- Keywords
- Peripheral Neuropathies, Testicular Cancer, Cisplatin, Pharmacogenomics
- Medical subject headings
- Peripheral Nervous System Diseases, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Six tubes of blood will be collected during one blood draw.
Report of peripheral neuropathy after cisplatin therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sample collection; Behavioral: 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. Receives: Procedure: Blood sample collection; Behavioral: Report of peripheral neuropathy after cisplatin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startDec 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nervous System DiseasesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Costantine Albany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantine Albany, Indiana University
- Investigators
- Costantine Albany, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492360
- Sponsor's protocol ID
- IRB #1504498959 (IUSCC-0516)
- Status last verified
- Feb 2018
- First submitted
- 13 May 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02492360
- Acronym / sponsor ID
- IRB #1504498959 (IUSCC-0516)
- Keywords
- Peripheral Neuropathies, Testicular Cancer, Cisplatin, Pharmacogenomics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Costantine AlbanyUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Jul 2015 (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.
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.
Detailed description
Primary Objective-To establish a biobank of specimens that allows for the future creation of iPS cells with the potential to make human neurons for functional studies of specific genes/genetic variants.
Secondary Objectives-To develop a clinically relevant in vitro model of cisplatin induced peripheral neuropathy to be used to 1) screen new drugs for the treatment or prevention of peripheral neuropathy; 2) evaluate candidate genes for their role in cisplatin induced neuropathy.
Study Procedures-Subjects who wish to participate will undergo the following study procedures, which will be performed after the informed consent document is obtained:
- Sample Collection-A trained phlebotomist will conduct a blood draw for the collection of SIX samples for peripheral blood mononuclear cell (PBMC) isolation and infectious disease testing.
- Patient Self-Report of Toxicities-All patients in the study will be asked to fill out the Patient-reported Toxicity Form. This will take approximately 10 minutes to complete and consists of 20 questions related to patient symptoms describing toxicities experienced secondary to receiving cisplatin chemotherapy. They will be asked to fill out the form twice: (1) describing the peripheral neuropathy they currently are experiencing and (2) describing the worst peripheral neuropathy toxicity they experienced as a result of cisplatin therapy. These paper forms will be filled out at time of enrollment in the study.
- Physician Report of Toxicities-The patient's physician or the designatee will complete an adverse event form at day of enrollment detailing the physician's assigned grade of toxicities (according to CTCAE version 4.3) experienced from cisplatin. Other information regarding the particularly severe neurotoxicity may also be collected from physicians (e.g. patient use of walker or wheelchair, patient application for disability based on neuropathy).
- General Information- This information will be collected at the same time point as all of the other study procedures (i.e., Day One). This will include but may not be limited to: age, height, weight, patient-identified race and ethnicity, information about the chemotherapy regimen, total cisplatin dose administered and date of last cisplatin dose.
- Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded. Outside records will be obtained where needed.
- Follow-up and Duration of Follow-Up-There will be no subsequent patient follow-up after time of enrollment. Subjects may withdraw consent for specimen use by contacting the PI in writing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Toxicity Group | – | Procedure: Blood sample collection, Behavioral: Report of peripheral neuropathy after cisplatin therapyDiagnosis 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 | – | Procedure: Blood sample collection, Behavioral: Report of peripheral neuropathy after cisplatin therapyDiagnosis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Blood sample collectionSix tubes of blood will be collected during one blood draw. | Procedure or surgery | Control Group, Severe Toxicity Group |
| Report of peripheral neuropathy after cisplatin therapyTwenty 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. | Behavioural | Control Group, Severe Toxicity Group |
Primary outcome
Biobank of peripheral blood mononuclear cells (PBMCs)
Time frame: Once (at enrollment)
PBMCs will be used for the future creation of iPS cells with the potential to make human neurons
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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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.
Costantine Albany, MD principal investigator
Indiana University
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 Peripheral Nervous System Diseases and Testicular Neoplasms, run by Costantine Albany 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 12 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Feb 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Biobank of peripheral blood mononuclear cells (PBMCs) (time frame: Once (at enrollment)). 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 28 Feb 2018.