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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 60000

Contacts and Locations

• Study Contact: Name: Fengwei Tan, MD-PhD; Phone Number: +8601087787792; Email: tanfengwei@126.com
• Study Contact Backup: Name: Renda Li, MD; Email: lirenda@cicams.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Fengwei Tan, MD; Phone Number: 010-87787790; Email: tanfengwei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with surgically resected lung cancer; Patients who were diagnosed with lung cancer and received surgical resection in participating medical centers during the designed study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from surgery to death from any cause.	January 2014 to December 2031

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics of included participants	Demographics, symptoms at diagnosis, tobacco exposure, family history, previous medical history, etc.	January 2014 to December 2028
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
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
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.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Jie He, MD-PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS and PUMC

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Lung cancer; Real world
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: LungReal_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No