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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.

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

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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Patients where further cancer treatment is no longer applicable.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.

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

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

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

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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