Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369181
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-12
Brief Title:
Neuroendocrine Transformation in RB1TP53 Inactivated NSCLC
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Neuroendocrine Transformation in RB1 and TP53 Inactivated Non-small Cell Lung Cancer Patients a Multi-center Prospective Observational Study
Status:
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:
Histology transformation from non-small cell lung cancer NSCLC to neuroendocrine carcinomas NEC especially from epidermal growth factor receptor EGFR mutant lung adenocarcinoma LADC to small cell lung cancer SCLC is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors TKIs resistance The probability of its occurrence is about 3-14 in NSCLC patients who are resistant to TKI treatment In addition to EGFR mutations NSCLC patients carrying ALKROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformationNET
In a previous study Pubmed ID 35609408 the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments This phenomenon could be under-recognized because re-biopsy was less frequently performed in these patients The investigators had also shown that p53Rb inactivation might correlated with NET and should be considered for NET risk prediction In another retrospective studies it was found that NSCLC patients with RB1TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1TP53 inactivation mutations 43 times higher than those without mutations Therefore the subgroup of NSCLC patients with tumor suppressor gene RB1TP53 dual inactivation might have elevated risk for NET
In this study the investigators proposed to prospectively follow up NSCLC patients with dual RB1TP53 inactivation approximately 5 of the total NSCLC Through prospective and systematic collection of baseline pathological information clinical treatment process and imaging data and as much as possible repeat pathological biopsies will be performed during disease progression
In a previous study Pubmed ID 35609408 the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments This phenomenon could be under-recognized because re-biopsy was less frequently performed in these patients The investigators had also shown that p53Rb inactivation might correlated with NET and should be considered for NET risk prediction In another retrospective studies it was found that NSCLC patients with RB1TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1TP53 inactivation mutations 43 times higher than those without mutations Therefore the subgroup of NSCLC patients with tumor suppressor gene RB1TP53 dual inactivation might have elevated risk for NET
In this study the investigators proposed to prospectively follow up NSCLC patients with dual RB1TP53 inactivation approximately 5 of the total NSCLC Through prospective and systematic collection of baseline pathological information clinical treatment process and imaging data and as much as possible repeat pathological biopsies will be performed during disease progression
Detailed Description:
None
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