Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

NCT02301858 | Unknown

• 1 other identifier: SIV 9743
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Primary Tumor; Metastases

Keywords

molecular pathology; functional genomics; lung cancer; primary tumor; metastases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study arm

OTHER

Genome analysis of tissue samples.

Genetic: Genome analysis of tissue samples.

Interventions

Genome analysis of tissue samples. GENETIC

Genome analysis of tissue samples.

Study arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastasizing lung cancer where further treatment is still applicable.

You may not qualify if:

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• Patients where further cancer treatment is no longer applicable.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

Sponsors & Collaborators

• Janna Berg: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

NO (1)