Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-04-25
Brief Title:
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy
Detailed Description:
The primary aim of this study is to validate the protein neurofilament light chain NFL as a biomarker of the side effect paclitaxel-induced peripheral neuropathy PIPN and its utility in predicting this side effect in patients with breast cancer The investigators want to include 188 patients at four different trial sites The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain NFL before and during treatment The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4
The primary endpoint of the study is if serum NFL100 pgml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain NFL before and during treatment The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4
The primary endpoint of the study is if serum NFL100 pgml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None