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

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 - BCT-BRAF-OzD-2019

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017491

Enrollment

Registered

2019-06-19

Start date

2019-06-21

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

C43 C34 C18 J90

Interventions

Group 1: As part of the study, the therapeutically extracted pleural effusion will be examined once by using the fully automatic diagnostic system Idylla ™ from BIOCARTIS. The aim is to examine whethe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Absence of the written consent of the patient

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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; Determination of the temporal benefit of the method compared to the standard procedure using Next Generation Sequencing	—

Countries

Germany

Contacts

Public ContactKarsten Ziegler

Onkologiezentrum Donauwörth

karsten.ziegler@onko-medeor.de+49 (0) 172-7473716

Outcome results

None listed

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