Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00958555
Status:
UNKNOWN
Last Update Posted:
2014-01-14
First Post:
2009-08-11
Brief Title:
A Study of Predictive and Prognostic Markers in Patients With Non-small Cell Lung Cancer
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
A Study of Predictive and Prognostic Markers in Patients With Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
1 To establish a retrospective compilation of clinical histopathological treatment and follow-up clinic pathological data of previous non-small cell lung cancer NSCLC cases
2 To establish a prospective collection of clinic pathological information from NSCLC patients with corresponding blood and tissue samples
3 To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC
One of the current difficulties in the management of lung cancer is the decision to treat and the type of treatment to select Thus there is a need for additional prognostic indicative of disease aggressiveness and predictive indicative of likely response to treatment markers for lung cancer To conduct a successful prognostic and predictive marker program several factors are required including a comprehensive database linking clinical histopathological treatment and outcome characteristics of each case a collection of samples linked to the database that is suitable for the testing of candidate markers and a multi-disciplinary interdepartmental level of expertise in the management of lung cancer
Objective 1
A review of the case records will be conducted to extract clinical treatment and follow-up data
Objective 2
Patients aged 21 years or more with newly diagnosed untreated non-small cell lung cancer shall be approached for consent Patients will be identified through the pathology records and from the study investigators clinic After subject consent baseline characteristics will be obtained Follow up data on therapies received and toxicities encountered will be obtained Tumor samples will be obtained only from patients with NSCLC undergoing surgery as part of routine clinical care The surgical specimen will be sent to Pathology to verify the adequacy of the diagnostic sample as per usual practice Blood will be collected at the baseline or prior to any anti-cancer treatment and will be sampled again at the time of relapse or disease progression Collection will entail drawing 7ml blood into a Vacutainer CPT tube Becton Dickinson USA centrifugation extraction of a separated layer of mononuclear cells MNC labeling followed by storage below -80oC The frequency of blood drawn will be about 1-5 times 7-35mls total The number of times depends on whether the lung cancer relapses and in the advanced stage how often the lung cancer relapses after treatment DNA and RNA will be extracted by CSIS and stored in freezer space there Stored samples will be used for investigation of prognostic and predictive markers of outcome and for discovery of novel molecular alterations
Objective 3
Biomarker analysis of tumor and blood Blood will be enriched for circulating tumor cells CTC using previously optimized methods 11 and DNA will be extracted from CTC and tumor using the Tri-Reagent Molecular Research Center Cincinatti OH DNA will be extracted from tumor CTC and mononucleated cells and tested for somatic lung mutations by sequencing 2 Germline DNA will be analysed for genes linked to genetic risk for NSCLC and for treatment toxicities for genes related to NSCLC chemotherapy metabolic pathways
Tissue microarray TMA is a high-throughput method of analysing large numbers of formalin-fixed paraffin-embedded tumor at a minimal cost and effort To analyse the expression of proteins of putative relevance to EGFR function cell proliferation angiogenesis apoptosis metastasis and hormonal TMA will be utilised PTEN and CEBPa will also be analysed
2 To establish a prospective collection of clinic pathological information from NSCLC patients with corresponding blood and tissue samples
3 To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC
One of the current difficulties in the management of lung cancer is the decision to treat and the type of treatment to select Thus there is a need for additional prognostic indicative of disease aggressiveness and predictive indicative of likely response to treatment markers for lung cancer To conduct a successful prognostic and predictive marker program several factors are required including a comprehensive database linking clinical histopathological treatment and outcome characteristics of each case a collection of samples linked to the database that is suitable for the testing of candidate markers and a multi-disciplinary interdepartmental level of expertise in the management of lung cancer
Objective 1
A review of the case records will be conducted to extract clinical treatment and follow-up data
Objective 2
Patients aged 21 years or more with newly diagnosed untreated non-small cell lung cancer shall be approached for consent Patients will be identified through the pathology records and from the study investigators clinic After subject consent baseline characteristics will be obtained Follow up data on therapies received and toxicities encountered will be obtained Tumor samples will be obtained only from patients with NSCLC undergoing surgery as part of routine clinical care The surgical specimen will be sent to Pathology to verify the adequacy of the diagnostic sample as per usual practice Blood will be collected at the baseline or prior to any anti-cancer treatment and will be sampled again at the time of relapse or disease progression Collection will entail drawing 7ml blood into a Vacutainer CPT tube Becton Dickinson USA centrifugation extraction of a separated layer of mononuclear cells MNC labeling followed by storage below -80oC The frequency of blood drawn will be about 1-5 times 7-35mls total The number of times depends on whether the lung cancer relapses and in the advanced stage how often the lung cancer relapses after treatment DNA and RNA will be extracted by CSIS and stored in freezer space there Stored samples will be used for investigation of prognostic and predictive markers of outcome and for discovery of novel molecular alterations
Objective 3
Biomarker analysis of tumor and blood Blood will be enriched for circulating tumor cells CTC using previously optimized methods 11 and DNA will be extracted from CTC and tumor using the Tri-Reagent Molecular Research Center Cincinatti OH DNA will be extracted from tumor CTC and mononucleated cells and tested for somatic lung mutations by sequencing 2 Germline DNA will be analysed for genes linked to genetic risk for NSCLC and for treatment toxicities for genes related to NSCLC chemotherapy metabolic pathways
Tissue microarray TMA is a high-throughput method of analysing large numbers of formalin-fixed paraffin-embedded tumor at a minimal cost and effort To analyse the expression of proteins of putative relevance to EGFR function cell proliferation angiogenesis apoptosis metastasis and hormonal TMA will be utilised PTEN and CEBPa will also be analysed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None