Paired analysis of microRNAs from whole blood cells in patients with lung diseases

• Conditions: J44; C34; Malignant neoplasm of bronchus and lung; Other chronic obstructive pulmonary disease

• Registration Number: DRKS00023138
• Lead Sponsor: Hummingbird Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-25
• Study Completion: 2022-06-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

The following patients are included: Group 1) Patients with suspected early stage lung cancer (stage I / II); and Group 2) patients with benign lung diseases (e.g. COPD or benign mass in the lungs); between the ages of 55 and 80 years (male or female). Further inclusion criteria are a current or ex-smoker status with = 30 pack years and with nicotine abstinence <15 years (if ex-smoker).

Exclusion Criteria

Exclusion criteria are:
• known chronic, infectious diseases (HIV, HCV, HBV)
• an advanced cancer treated curatively in the past 5 years
• immunomodulatory or neoadjuvant therapy that has already started
• invasive diagnostics before inclusion in the study
• anemia

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of an expression catalog (base matrix) of the short-chain and long-chain RNAs of the cells of the peripheral blood.

Secondary Outcome Measures

Name	Time	Method
The aim is also to evaluate how exactly different commercially available blood collection systems (PAXgene, Tempus, Norgen cfRNA, Mitra unit) map the physiological miRNA profiles of the blood.