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Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

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ClinicalTrials.gov Identifier: NCT02301858
Recruitment Status : Recruiting
First Posted : November 26, 2014
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Janna Berg, Sykehuset i Vestfold HF

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. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : December 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301858


Contacts
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Contact: Janna Berg +47 928 35 703 jannaberg1@gmail.com

Locations
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Norway
Vestfold Hospital Trust Recruiting
Tønsberg, Norway, 3103
Contact: Janna Berg    4792835703    jannaberg1@gmail.com   
Contact: Åslaug Helland, PhD       aslaug.helland@gmail.com   
Sponsors and Collaborators
Janna Berg
Oslo University Hospital

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Responsible Party: Janna Berg, Consultant, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02301858     History of Changes
Other Study ID Numbers: SIV 9743
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Keywords provided by Janna Berg, Sykehuset i Vestfold HF:
molecular pathology
functional genomics
lung cancer
primary tumor
metastases

Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes