Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-27
Brief Title:
Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Prospective Study on the Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC Based on Proteomics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Non-small cell lung cancer NSCLC occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide afflicts an estimated 30 of its patients with intracranial metastatic spread Among these leptomeningeal metastasis LM is an exceptionally surreptitious and perilous manifestation often evading timely and accurate diagnosis The clinical landscape is further complicated by the presence of patients who due to various reasons are unable to undergo lumbar puncture a procedure crucial for the investigation of LM Moreover even when cerebrospinal fluid CSF analysis via conventional cytological and immunohistochemical methods is attempted a definitive diagnosis of LM may remain elusive in a subset of cases
Intrathecal chemotherapy particularly via the administration of pemetrexed which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space constitutes a cornerstone of treatment for NSCLC-LM Despite its importance the lack of robust validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap This deficit is compounded by the inherent challenges associated with CSF samples including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques
To address these pressing diagnostic and monitoring needs in NSCLC-LM management the investigator proposes a forward-looking non-interventional clinical study harnessing the power of cutting-edge proteomic technologies These platforms characterized by their high throughput exquisite sensitivity and minimal sample volume requirements offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy ultimately contributing to enhanced patient care and personalized therapeutic strategies
Intrathecal chemotherapy particularly via the administration of pemetrexed which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space constitutes a cornerstone of treatment for NSCLC-LM Despite its importance the lack of robust validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap This deficit is compounded by the inherent challenges associated with CSF samples including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques
To address these pressing diagnostic and monitoring needs in NSCLC-LM management the investigator proposes a forward-looking non-interventional clinical study harnessing the power of cutting-edge proteomic technologies These platforms characterized by their high throughput exquisite sensitivity and minimal sample volume requirements offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy ultimately contributing to enhanced patient care and personalized therapeutic strategies
Detailed Description:
The research is structured into two distinct phases In the inaugural segment the investigator plans to assemble a comprehensive dataset by procuring plasma or cerebrospinal fluid CSF samples from 30 individuals presenting with confirmed CSF positivity for LM juxtaposed against an equal number of advanced NSCLC cases manifesting neither clinical signs nor radiographic indicators of meningeal involvement These biological materials will be subjected to rigorous proteomic interrogation with the overarching goal of discerning distinctive proteomic signatures that can accurately discriminate between NSCLC patients with and without LM
In the subsequent phase the studys focus shifts to therapeutic response monitoring Maintaining the same cohort of CSF-positive NSCLC-LM patients initially recruited in Phase One the researcher will systematically collect plasma and CSF samples at critical junctures during their treatment trajectory specifically within the two-week period preceding intrathecal chemotherapy initiation establishing a baseline immediately following the intervention at T0 24 hours post-administration and at the T28 milestone 28 days post-injection Simultaneously meticulous documentation of each patients treatment response disease progression dynamics and overall survival metrics will be meticulously compiled This concerted effort is designed to harness the power of proteomics in providing a real-time molecular snapshot of chemotherapy effectiveness thereby offering invaluable insights into the therapeutic efficacy of intrathecal chemotherapy in the context of NSCLC-LM management
In the subsequent phase the studys focus shifts to therapeutic response monitoring Maintaining the same cohort of CSF-positive NSCLC-LM patients initially recruited in Phase One the researcher will systematically collect plasma and CSF samples at critical junctures during their treatment trajectory specifically within the two-week period preceding intrathecal chemotherapy initiation establishing a baseline immediately following the intervention at T0 24 hours post-administration and at the T28 milestone 28 days post-injection Simultaneously meticulous documentation of each patients treatment response disease progression dynamics and overall survival metrics will be meticulously compiled This concerted effort is designed to harness the power of proteomics in providing a real-time molecular snapshot of chemotherapy effectiveness thereby offering invaluable insights into the therapeutic efficacy of intrathecal chemotherapy in the context of NSCLC-LM management
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?:
None
Is an FDA AA801 Violation?:
None