Preoperative risk stratification of lung lesions of unclear dignity by using the EarlyCDT®-Lung test for clinical suspicion of lung carcinoma

Recruiting

Conditions: C34
R91
Malignant neoplasm of bronchus and lung
Abnormal findings on diagnostic imaging of lung

Registration Number: DRKS00028546

Lead Sponsor: Klinik für Thoraxchirurgie, Krankenhaus Martha-Maria Halle-Dölau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

Patients with lung foci that appear suspicious for lung carcinoma and are submitted to surgical histology recovery; multiple round foci may be included; Written informed consent must be obtained

Exclusion Criteria

Patients younger than 18 years; non-consenting patients, carcinomas of other types (not lung carcinoma) that occurred less than 5 years ago, recurrences of carcinomas within the last 5 years.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of the study is on the one hand to validate the antibody test and on the other hand to correlate the other preoperative tests with the EarlyCDT in order to be able to make a statement about a more precise diagnosis and early detection. In addition to the CDT, PET-CT, HR-CT and anamnestic data are taken into account, which can be read in the study protocol below. Further measurement instruments are the postoperative histological confirmation of the suspected diagnosis. A CRF sheet will be used for the anamnestic survey.

Secondary Outcome Measures

Name	Time	Method
Another long-term goal of the study is to reduce the incidence of lung carcinomas III and IV and thus also to reduce lethality. This is accompanied by the establishment of a system for prevention and early detection - i.e. screening procedures.