Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT02492360
Status:
WITHDRAWN
Last Update Posted:
2018-02-28
First Post:
2015-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy
Sponsor:
Costantine Albany
Organization:
Study Overview
Official Title:
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
1. 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.
2. 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.
3. 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).
4. 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.
5. Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded. Outside records will be obtained where needed.
6. 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.
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:
1. 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.
2. 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.
3. 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).
4. 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.
5. Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded. Outside records will be obtained where needed.
6. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: