Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

Sponsor

Janna Berg (Other)

Overall Status

Recruiting

CT.gov ID

NCT02301858

Collaborator

Oslo University Hospital (Other)

100

Enrollment

Location

Arm

144

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Primary Tumor Metastases	Genetic: Genome analysis of tissue samples.	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Study arm Genome analysis of tissue samples.	Genetic: Genome analysis of tissue samples. Genome analysis of tissue samples.

Arm

Intervention/Treatment

Other: Study arm

Genome analysis of tissue samples.

Genetic: Genome analysis of tissue samples.

Genome analysis of tissue samples.

Outcome Measures

Primary Outcome Measures

Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung [5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.