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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255197
• Other study ID #: LungReal_01
• Status: Recruiting
• Start date: November 4, 2019
• Est. completion date: December 31, 2031

Study information

• Verified date: January 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Fengwei Tan, MD-PhD
• Phone: +8601087787792
• Email: tanfengwei[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Lung Cancer
• Lung Neoplasms
• Lung Squamous Cell Carcinoma
• Non Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time from surgery to death from any cause.	January 2014 to December 2031
Secondary	Baseline characteristics of included participants	Demographics, symptoms at diagnosis, tobacco exposure, family history, previous medical history, etc.	January 2014 to December 2028
Secondary	Treatment patterns of included participants	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.	January 2014 to December 2028
Secondary	Pathological characteristics of included participants	Location, size, classification, presence or absence of certain pathological features of resected tumor(s); number of metastasized and dissected lymph nodes in each station.	January 2014 to December 2028
Secondary	Features associated with overall survival	Features within the range of collected baseline characteristics, treatment patterns and pathological characteristics that are associated with overall survival.	First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.