Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-27 @ 2:48 PM
Study NCT ID:
NCT03998332
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study
Sponsor:
Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Organization:
Study Overview
Official Title:
Overall Survival and Progression Free Survival of Patients With Large Cell Neuroendocrine Lung Cancer and Combined Large Cell Neuroendocrine Lung Cancer Treated in Clinical Stage I-IV
Status:
COMPLETED
Status Verified Date:
2019-06
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:
This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.
Detailed Description:
This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.
For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.
The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.
The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.
For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.
The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.
The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.
Study Oversight
Has Oversight DMC:
False
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?: