Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Metastases; Primary Tumor
• Interventions: Genetic: Genome analysis of tissue samples.

• Registration Number: NCT02301858
• Lead Sponsor: Janna Berg

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-11-23
• Study First Posted: 2014-11-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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• Patients where further cancer treatment is no longer applicable.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Genome analysis of tissue samples.	Genome analysis of tissue samples.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway