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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02301858
Other study ID # SIV 9743
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date December 2025

Study information

Verified date January 2023
Source Sykehuset i Vestfold HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 - Patients where further cancer treatment is no longer applicable.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


Intervention

Genetic:
Genome analysis of tissue samples.
Genome analysis of tissue samples.

Locations

Country Name City State
Norway Vestfold Hospital Trust Tønsberg

Sponsors (2)

Lead Sponsor Collaborator
Janna Berg Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
5 years
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