Non-small-cell Lung Cancer Clinical Trial
— C-TALKOfficial title:
A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer (NSCLC) Patients With ALK Positive in China
Verified date | February 2017 |
Source | Guangdong Association of Clinical Trials |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3649 |
Est. completion date | July 6, 2016 |
Est. primary completion date | April 15, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong General Hospital | Guangzhou | Guangdong |
China | Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Association of Clinical Trials |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally. | one and half years | ||
Primary | the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer | one and half years | ||
Secondary | demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients | one and half years |
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