A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing: The ASSESS Study

A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing: The ASSESS Study - ASSESS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38725

Enrollment

120

Registered

2013-10-01

Start date

2013-12-05

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Provision of written informed consent. - Patients aged 18 years and older from European countries and patients aged 20 years and - older for patients from Japan. - Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC. - Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI). - Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable). - Provision of a routine blood (plasma) sample.

Exclusion criteria

Exclusion criteria: - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) - Previous enrolment in the present study - As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) - Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study. - Pregnancy or breast-feeding

Design outcomes

Secondary

Measure	Time frame
In addition the study will also collect information about NSCLC, result of the EGFR mutation test, how the EGFR mutation test is performed in the laboratory, and what effect the EGFR mutation test result has on the choice of drugs used to treat NSCLC.	—

Primary

Measure	Time frame
The study will establish whether blood (plasma) is a suitable sample type for reliably determining the EGFR mutation status of patients with NSCLC compared with cytology/tumour tissue.	—

Countries

Netherlands

Outcome results