Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers

Recruiting

• Conditions: Non Small Cell Lung Cancer; Lung Adenocarcinoma; Small-cell Lung Cancer; Lung Cancer; Lung Squamous Cell Carcinoma

• Registration Number: NCT06255197
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2019-11-04
• Status Verified: 2024-01
• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-04
• Study First Posted: 2024-02-13
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-16
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	January 2014 to December 2031	Time from surgery to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Pathological characteristics of included participants	January 2014 to December 2028	Location, size, classification, presence or absence of certain pathological features of resected tumor(s); number of metastasized and dissected lymph nodes in each station.
Features associated with overall survival	First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.	Features within the range of collected baseline characteristics, treatment patterns and pathological characteristics that are associated with overall survival.
Treatment patterns of included participants	January 2014 to December 2028	Extent of lung resection and lymph node dissection, application of certain surgical techniques or not; application of chemotherapy, targeted therapy, immunotherapy and/or radiotherapy before and/or after surgery.
Baseline characteristics of included participants	January 2014 to December 2028	Demographics, symptoms at diagnosis, tobacco exposure, family history, previous medical history, etc.

Trial Locations

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China