Clinical trial NCT06255197: Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Official title: Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung Adenocarcinoma
Lung Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Keywords: Lung cancer
Surgery
Real world
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants eligible for this study would be screened from consecutive patients who received surgical resection for lung malignancies in participating medical centers during the designed study period.

Brief summary: This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe characteristics and treatment patterns and their evolving trends; (2) discover features associated with overall survival; and (3) address recently-emerging clinical questions.

Detailed description: Lung cancer is the leading cause of cancer-related deaths in China. The recent decade witnessed rapid evolving of demographics, pathological features and prognoses of patients with surgically resected lung cancers. The introduction of minimally invasive surgery (MIS) concept and techniques, targeted therapy and immunotherapy changed treatment landscape for patients with surgically resected lung cancers. With more early-stage lung cancers discovered due to the application of CT screening, questions focusing on extent of lung resection, lymph node dissection, application of targeted or immune-therapy to early-stage lung cancers are emerging. This study aims to create a cohort of patients with surgically resected lung cancers and an analytic framework to address the aforementioned clinical questions.

Eligibility criteria: Inclusion Criteria:

* Age above 18.
* Have received surgical resection for lung malignancies.

Exclusion Criteria:

* Participants whose data are of low quality, poor completeness or poor internal linkage.

Primary outcomes:
measure: Overall survival
timeFrame: January 2014 to December 2031
Secondary outcomes:
measure: Baseline characteristics of included participants
timeFrame: January 2014 to December 2028
measure: Treatment patterns of included participants
timeFrame: January 2014 to December 2028
measure: Pathological characteristics of included participants
timeFrame: January 2014 to December 2028
measure: Features associated with overall survival
timeFrame: First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS and PUMC
name: Jie He, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: