Short summary

In this project we wish to improve our methods for diagnosing lung cancer in early stages.

This projekt consist of a randomized clinical trial where we examine the benefits os using a multimodal aproach when performing endoscopic examinations of the lungs.

Furthermore we wish to examine whether DNA from tumor cells can be found in fluid from the lungs collected during endoscopic examinations.

Rationale

Background for the overall project: Lung cancer is the primary cause of cancer related deaths in Denmark. In order to improve the prognosis, diagnosis in earlier stages are needed.

Screening or easy access to CT of the chest may help to identify patients with possible early stage lung cancer.

Biopsy sampling for obtaining the diagnosis is not without risks, and if the lesion is small performing the examination can be difficult. One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, which enables the proceduralist to perform radial endobronchial ultrasound (rEBUS) to more accurately identify the lung lesions before sampling them. The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion Apart from improvements in the bronchoscopic techniques, new alternative diagnostic methods are also being developed. Aberrant methylation of the HOXA9 gene occurs in almost all malignant lung tumors and circulationg tumor DNA (ctDNA) could potentially be used diagnostically.

The NEBULA study

Background:

ENB has in recent year become a part of standard lung cancer work-up. Another method is rEBUS in which an ultrasound probe is used to locate the lesion before tissue sampling.

Aim

The aim of this study is to assess whether the combination of rEBUS and ENB is superior to ENB for biopsy sampling small peripheral lung lesions. Furthermore, we aim to assess the hospital costs of the entire work-up when combining rEBUS/ENB compaired to ENB alone.

Clinical impact:

The results will help to clarify how one of the most important diagnostic procedures for patients with suspected lung cancer due to a peripheral lung lesion should be used in clinical practice. The results of the project can be directly implemented at a national scale once the results are available.

The DRILL study

Background

In a pilot study ctDNA in bronchial lavage has been associated with lung cancer and may be a future tool for minimally invasive diagnosis.

Aim:

The DRILL project examines whether the detecting af ctDNA in BL can be used as an additional tool to improve the diagnostic yield of biopsy sampling.

Clinical relevance:

A pilot study has shown a correlation between lung cancer and ctDNA in BL. This study will help establish whether the correlation can be used in a clinical setting. If the collection of ctDNA in combination with tissue sampling has a better diagnostic yield than tissue sampling alone, it will prevent repeated procedures for some patients.

Description of the cohort

The cohort consist of 200 patients undergoing examination for lung cancer due to a peripheral lung lesions. All patients must be above the age of 18.

Data and biological material

Information from the patients medical records, blood, bronchial lavage fluid, tissue samples from the lungs, questionnaires.

Collaborating researchers and departments

Department of Respiratory Medicine, Aarhus University Hospital

• Associate Professor Torben Riis Rasmussen

Department of Medicine, Lillebaelt Hospital, Vejle

• Professor Ole Hilberg

Department of Oncology, Lillebaelt Hospital, Vejle

• MD Sara Witting Christensen Wen

Department of Medicine, Roskilde University Hospital

• Associate Professor Paul Clementsen