Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy

Wissenschaftliches Institut Bethanien e.V

Status: Completed

Conditions: Lung Neoplasms

Treatments: Procedure: EBUS-TBNA; Procedure: Endobronchial forceps biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03017183

WI_EBUS-TBNA_16-226

Details and patient eligibility

About

Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.

Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.

The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.

Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.

Enrollment: 30 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Informed consent: a signed and dated written informed consent prior to study participation.
2. Type of subject: inpatient
3. Age: subjects of more than 18 years and less than 85 years.
4. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
5. Central lesion has to be accessible by the biopsy techniques under investigation

Exclusion criteria

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
2. Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl)
3. Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
4. Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

EBUS-TBNA - Endobrochial Forceps Biopsy

Other group

Description:

In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy

Treatment:

Procedure: EBUS-TBNA

Procedure: Endobronchial forceps biopsy

Forceps - EBUS-TBNA

Other group

Description:

In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA

Treatment:

Procedure: EBUS-TBNA

Procedure: Endobronchial forceps biopsy