Investigation of the BRAF mutation status in the pleural punctate in patients with malignant melanoma, colorectal or lung cancer, that show a BRAF mutation in the primary tumor and the comparison of the result with the conventional cytological / immunohistochemical and molecular cytology findings of the pleural punctate

Recruiting

• Conditions: C43; C34; C18; J90; Malignant melanoma of skin; Malignant neoplasm of bronchus and lung; Malignant neoplasm of colon; Pleural effusion, not elsewhere classified

• Registration Number: DRKS00017491
• Lead Sponsor: Onkologiezentrum Donauwörth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Reliable diagnosis of malignant melanoma, mCRC or NSCLC;

Need for a regular therapy-related pleural puncture;

BRAF-V600 mutation already detected by NGS procedure in the primary tumor;

Signed informed consent form

Exclusion Criteria

Absence of the written consent of the patient

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigation of the possibility to increase the sensitivity of diagnoses of malignant pleural effusion compared to conventional pleural cytology by using the Idylla ™ ctBRAF mutation assay

Secondary Outcome Measures

Name	Time	Method
Investigation of whether the method is also suitable as a companion diagnostic for the detection of a BRAF-V600 mutation in the area of ??pleural carcinosis without the need for cell preparation on the pleural effusion;<br>Determination of the temporal benefit of the method compared to the standard procedure using Next Generation Sequencing