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Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens

M

Maggiore Bellaria Hospital, Bologna

Status

Completed

Conditions

Non-small Cell Lung Cancer

Treatments

Other: Rapid on-site evaluation
Device: EBUS-TBNA

Study type

Interventional

Funder types

Other

Identifiers

NCT01799382
13001-Trisolini

Details and patient eligibility

About

The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.

Enrollment

126 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years
  • Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion criteria

  • Pregnancy
  • Uncontrolled coagulopathy
  • Refusal to sign informed consent

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

126 participants in 2 patient groups

EBUS-TBNA + Rapid on-site evaluation
Experimental group
Description:
Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA
Treatment:
Other: Rapid on-site evaluation
Device: EBUS-TBNA
EBUS-TBNA
Active Comparator group
Description:
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
Treatment:
Device: EBUS-TBNA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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