Clinical trial NCT02042105: A Prospective Epidemiologic Study of ALK-Positive NSCLC in China
Official title: A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer (NSCLC) Patients With ALK Positive in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small-cell Lung Cancer
Keywords: non-small-cell lung cancer
anaplastic lymphoma kinase
immunohistochemistry
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 3649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unselected Chinese patients with non-small-cell lung cancer

Brief summary: This is a post-marketing, observational, non-interventional, multi-central study of patients with non-small cell lung cancer (NSCLC), with data collected prospectively from medical records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.

Detailed description: Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology. ALK positive status will be detected by Ventana immunohistochemistry (IHC) (Ventana Medical Systems, Inc. and Roche Diagnostics International, Inc). When ALK positive patients are detected, crizotinib will be administrated by various solutions based on physician's desecration and patients' willingness.

The secondary objectives include: 1.To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC.2.To describe demographic, socioeconomic \[such as age, gender, race/ethnicity, geographic location (including rural/urban area), pathologic parameters, education, family income, National Reimbursement Drug List (NRDL) or Provincial Reimbursement List (PRDL)\], and clinical characteristics of NSCLC patients with ALK positive.

The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years), both sex.
* Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.
* Written informed consent.

Exclusion Criteria:

* Those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (SCLC) or metastatic disease from other organs.

Primary outcomes:
measure: the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer
timeFrame: one and half years
Secondary outcomes:
measure: demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients
timeFrame: one and half years
Other outcomes:
measure: prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.
timeFrame: one and half years
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
name: Yi-Long Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Yi-Long Wu, MD
role: PRINCIPAL_INVESTIGATOR
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