Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
Primary Purpose
Lung Cancer, Primary Tumor, Metastases
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Genome analysis of tissue samples.
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring molecular pathology, functional genomics, lung cancer, primary tumor, metastases
Eligibility Criteria
Inclusion Criteria:
- Patients with metastasizing lung cancer where further treatment is still applicable.
Exclusion Criteria:
- Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
- Patients where further cancer treatment is no longer applicable.
- Patients with cognitive impairment.
- Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.
Sites / Locations
- Vestfold Hospital Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study arm
Arm Description
Genome analysis of tissue samples.
Outcomes
Primary Outcome Measures
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung
We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations.
Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.
Secondary Outcome Measures
Full Information
NCT ID
NCT02301858
First Posted
August 4, 2014
Last Updated
January 19, 2023
Sponsor
Janna Berg
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02301858
Brief Title
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
Official Title
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Janna Berg
Collaborators
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.
Detailed Description
The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Primary Tumor, Metastases
Keywords
molecular pathology, functional genomics, lung cancer, primary tumor, metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm
Arm Type
Other
Arm Description
Genome analysis of tissue samples.
Intervention Type
Genetic
Intervention Name(s)
Genome analysis of tissue samples.
Intervention Description
Genome analysis of tissue samples.
Primary Outcome Measure Information:
Title
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung
Description
We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations.
Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metastasizing lung cancer where further treatment is still applicable.
Exclusion Criteria:
Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
Patients where further cancer treatment is no longer applicable.
Patients with cognitive impairment.
Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.
Facility Information:
Facility Name
Vestfold Hospital Trust
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
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