Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654364
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2020-11-26
Brief Title:
Lung Cancer Registry
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
Official Title:
Lung Cancer Registry
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Lung cancer is the second most common cancer in Austria with 2868 men and 2009 women diagnosed in 2016 Reflecting the high mortality of this disease 2415 men and 1534 women died from lung cancer Therefore lung cancer is the most common reason for cancer associated death in men and second most common reason in women
This malignant disease can be divided into two main groups small cell lung cancer SCLC and non-small cell lung cancer NSCLC NSCLC is a paradigm for personalized medicine with an increasing number of targetable gene alterations Despite this growing diversity of molecular subtypes in most patients no targetable mutation can be detected For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy Until recently little progress has been made in the treatment of SCLC in last decades Recently an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported
Despite the progress in the treatment of NSCLC the performance of predictive biomarkers is weak Therefore the development of more precise prediction models is of great importance for the progress of personalized treatment strategies
This malignant disease can be divided into two main groups small cell lung cancer SCLC and non-small cell lung cancer NSCLC NSCLC is a paradigm for personalized medicine with an increasing number of targetable gene alterations Despite this growing diversity of molecular subtypes in most patients no targetable mutation can be detected For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy Until recently little progress has been made in the treatment of SCLC in last decades Recently an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported
Despite the progress in the treatment of NSCLC the performance of predictive biomarkers is weak Therefore the development of more precise prediction models is of great importance for the progress of personalized treatment strategies
Detailed Description:
This registry is designed as multicenter observational cohort of patients with lung cancer Patient medical testing and treatment information will be obtained through extraction of data from existing patient medical charts Longitudinal follow-up data including survival and tumor progression will also be extracted from patient medical charts This patient follow-up data will be obtained until patient death or loss to follow-up
For documentation in the registry no further diagnostic or therapeutic measures are required than those already necessary in general Participation in the registry must not interfere with treatment routines Only routine data which has already been recorded in the patients medical chart is transferred to the electronic Case Report Forms To maintain patient confidentiality each patient will be assigned a unique patient identifying number upon enrollment this number will accompany the patients medical and other registry information throughout the lifetime of the registry
A written consent must be obtained prior to the input of data No informed consent is required from deceased patients
Data will be collected from all sites willing to participate
For documentation in the registry no further diagnostic or therapeutic measures are required than those already necessary in general Participation in the registry must not interfere with treatment routines Only routine data which has already been recorded in the patients medical chart is transferred to the electronic Case Report Forms To maintain patient confidentiality each patient will be assigned a unique patient identifying number upon enrollment this number will accompany the patients medical and other registry information throughout the lifetime of the registry
A written consent must be obtained prior to the input of data No informed consent is required from deceased patients
Data will be collected from all sites willing to participate
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