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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028546
Enrollment
250
Registered
2022-04-01
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34 R91

Interventions

Group 1: Patients who have a suspicious pulmonary nodule in their medical history are included in the study. The first arm includes the "lung carcinoma" group. These patients serve as the study group.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactMarcus Krüger

Klinik für Thoraxchirurgie, Krankenhaus Martha-Maria Halle-Dölau

chirurgische-klinik2.halle@martha-maria.de03455591882

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026