Research with human participants

Overview of medical research in the Netherlands

Comparative analysis of KRAS and EGFR mutation detection in liquid biopsy vs tissue biopsy in patients with NSCLC

Published:
Last updated:

In this study, the agreement between liquid biopsy and tissue biopsy based KRAS/EGFR molecular diagnostics will be determined. Additionally, pairwise comparison of different liquid biopsy based molecular tests will be performed based on several…

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruiting
Health condition type
Respiratory and mediastinal neoplasms malignant and unspecified
Study type
Observational non invasive

ID

NL-OMON48625

Source

ToetsingOnline

Brief title

COMMUNIST

Condition

  • Respiratory and mediastinal neoplasms malignant and unspecified

Synonym

lung cancer, Non-small-cell lung carcinoma

Research involving

Human

Sponsors and support

Primary sponsor :
Jeroen Bosch Ziekenhuis
Source(s) of monetary or material Support :
Astra Zeneca,AstraZeneca

Intervention

Keyword :
Liquid biopsy, Lung cancer, Mutation detection

Outcome measures

Primary outcome

The agreement between liquid biopsy and tissue biopsy based KRAS/EGFR molecular

diagnostics that will be determined using Contigency table analysis and

comparison of parameters such as specificity, sensitivity, positive and

negative predictive values and Cohen*s kappa coefficient.

Secondary outcome

Not applicable.

Background summary

Routine molecular diagnostics on lung tumors is performed on a biopsy or after
resection of the tumor. However, lung tumor biopsy or obtaining representative
cytological material is regularly not successful/possible.
Currently, great progress is being made in the field of liquid biopsy where
molecular diagnostics is performed on blood and/or urine of the patient
involved. Liquid biopsy based molecular diagnostics could be a possible
alternative for or be complementary to mutational analysis on a tissue biopsy.
Moreover, a liquid biopsy is less invasive in comparison to a tissue biopsy.

Study objective

In this study, the agreement between liquid biopsy and tissue biopsy based
KRAS/EGFR molecular diagnostics will be determined. Additionally, pairwise
comparison of different liquid biopsy based molecular tests will be performed
based on several parameters such as sensitivity and specificity.

Study design

Observational/implementation study based on comparison of routine tissue biopsy
based KRAS/EGFR diagnostics with liquid biopsy based KRAS/EGFR diagnostics.

Study burden and risks

Not applicable.

Public
Jeroen Bosch Ziekenhuis

Deutersestraat 2
Den Bosch 5223 GV
NL
Scientific
Jeroen Bosch Ziekenhuis

Deutersestraat 2
Den Bosch 5223 GV
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Patients with NSCLC (initial diagnosis and progressive disease) that are eligible for KRAS/EGFR mutation analysis on tissue biopsy as performed for standard of care.

Exclusion criteria

Patients with NSCLC where tissue biopsy was not successful.

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
150
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL66646.028.18