Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

NCT ID: NCT02301858

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Lung Cancer; Primary Tumor; Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study arm

Genome analysis of tissue samples.

Group Type: OTHER

Genome analysis of tissue samples.

Intervention Type: GENETIC

Genome analysis of tissue samples.

Interventions

Genome analysis of tissue samples.

Genome analysis of tissue samples.

Intervention Type: GENETIC

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• Patients where further cancer treatment is no longer applicable.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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Janna Berg

OTHER

Sponsor Role: lead

Responsible Party

Janna Berg

Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vestfold Hospital Trust

Tønsberg, , Norway

Countries

Norway

Other Identifiers

SIV 9743

Identifier Type: -

Identifier Source: org_study_id