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

Lung Neoplasms Clinical Trial

Official title:

Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017183
• Other study ID #: WI_EBUS-TBNA_16-226
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2018
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Procedure:
• EBUS-TBNA
Endobronchial ultrasound guided transbronchial needle aspiration
• Endobronchial forceps biopsy
Conventional endobronchial forceps biopsy

Locations

Country	Name	City	State
Germany	Krankenhaus Bethanien gGmbH	Solingen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	AstraZeneca, Institute of Pathology, University Clinic Düsseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of detected mutations	The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined	within 7 days after biopsy