Clinical trial NCT03421093: A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies
Official title: A Multi-centre Real-world Non-interventional Observational Study to Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Chinese
surgeries
adjuvant therapies
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-02-05
Enrollment: 21777
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung malignant tumors who were performed with surgeries

Brief summary: The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors

Detailed description: The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old;
* Pathologically diagnosed lung malignant tumors after surgeries;
* Patients with lung surgeries;
* Patients with complete medical health records and follow-up visit information (at least one follow-up visit);

Exclusion Criteria:

* Patients who were not performed with surgeries;
* Pathologically diagnosed patients with benign diseases after surgeries;

Primary outcomes:
measure: Demographic characteristics of the patients with lung malignant tumors who received surgeries
timeFrame: 2014 - 2017
Secondary outcomes:
measure: Location of tumors and tumor sizes
timeFrame: 2014 - 2017
measure: Tumor clinical/pathological staging
timeFrame: 2014 - 2017
measure: Type of biomarkers
timeFrame: 2014 - 2017
Other outcomes:
measure: Differences in overall survivals of the patients with surgeries
timeFrame: 2014 - 2017
measure: Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by tumor clinical/pathological staging
timeFrame: 2014 - 2017
measure: Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by location of tumors and tumor sizes
timeFrame: 2014 - 2017
measure: Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by duration and modes of surgeries
timeFrame: 2014 - 2017
measure: Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by type of insurances
timeFrame: 2014 - 2017
measure: Overall survival in the patients with tumor size =< 2cm who received surgeries
timeFrame: 2014 - 2017
measure: Impact factors of patient survivals in the patients with N2 lung cancer with surgeries or surgeries plus adjuvant therapies
timeFrame: 2014 - 2017
measure: Overall survival in the patients with N2 lung cancer with surgeries or surgeries plus adjuvant therapies
timeFrame: 2014 - 2017
measure: Impact factors of patient survivals in the patients with small lung cancer with surgeries or surgeries plus adjuvant therapies
timeFrame: 2014 - 2017
measure: Overall survival in the patients with small lung cancer with surgeries or surgeries plus adjuvant therapies
timeFrame: 2014 - 2017
measure: Demographic characteristics of the patients with non-small cell lung cancer who were treated with chemotherapies, tyrosine kinase inhibitors, and other adjuvant therapies or were not treated with adjuvant therapies
timeFrame: 2014 - 2017
measure: Tumor clinical/pathological types
timeFrame: 2014 - 2017
measure: Type of EGFR
timeFrame: 2014 - 2017
measure: ECOG scores
timeFrame: 2014 - 2017
measure: 1-year and 3-year overall survivals
timeFrame: 2014 - 2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huaxi Technology University
state: Hubei
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Lunxun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: