Clinical Characteristics of Lung Cancer in China

Clinical Characteristics of Lung Cancer in China: 8-Year Population-Based Study

This study is a single-center, real-world and large-population-based retrospective study. In the current study, the investigators not only describe the changes of demographic and basic clinicopathological characteristics of lung cancer during recent years but delineate the correlation between clinicopathological features and common clinical blood tests in such a large population.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer

Detailed Description

In this study, the investigators will collected all lung cancer patients diagnosed in Shanghai Pulmonary Hospital from 2012 to 2020. By conducting this population based study, the investigators would like to delineate changes of characteristics of lung cancer in Chinese patients during these years. Meanwhile, the investigators will compare clinicopathological features, routine blood tests, blood biochemical tests and coagulation status among participants at different stages. This comparing will assist the investigators to understand systemic changes during lung cancer progression. The same comparison will also be conducted among participants having different driver mutation through which the investigators will further understand the characteristics of different patients and treat patients more precisely.

• Study Type: Observational
• Enrollment (Anticipated): 119785

Contacts and Locations

• Study Contact: Name: Yayi He, PhD, MD; Phone Number: +86 021-65115006; Email: doctorjael@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
      • Principal Investigator: Yayi He, PhD, MD
      • Contact: Yayi He, PhD, MD; Phone Number: +86 021-65115006; Email: doctorjael@qq.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population was patient who was diagnosed as lung cancer at Shanghai Pulmonary Hospital from January 1st, 2012 to October 31st, 2020.

Description

Inclusion Criteria:

1. Patients have medical records in our hospital.
2. Patients were diagnosed as lung cancer by pathological examination.

Exclusion Criteria:

1. Patients were lack of accurate pathological diagnoses.
2. Pathological diagnosis was benign disease or metastatic cancer from other organs.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive analysis of clinical characteristics of lung cancer of all participants	The changes of demographic characteristics and clinicopathological characteristics of Chinese lung cancer patients during the 8 years, from 2012 to 2020, will be analyzed.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of prothrombin time (PT) would be performed in all participants	The investigators collected the prothrombin time (PT) (the unit is second). Then the investigators would compare PT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of activated partial thromboplastin time (APTT) would be performed in all participants	The investigators collected the activated partial thromboplastin time (APTT) (the unit is second). Then the investigators would compare APTT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of thrombin time (TT) would be performed in all participants	The investigators collected the thrombin time (TT) (the unit is second). Then the investigators would compare TT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of fibrinogen would be performed in all participants	The investigators collected the blood fibrinogen content (the unit is gram per liter). Then the investigators would compare blood fibrinogen content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of D-dimer would be performed in all participants	The investigators collected the blood D-dimer content (the unit is nanogram per milliliter). Then the investigators would compare blood D-dimer content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of fibrinogen degradation product (FDP) would be performed in all participants	The investigators collected the blood fibrinogen degradation product (FDP) (the unit is microgram per milliliter). Then the investigators would compare blood FDP content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Complete blood cell count (CBC) would be performed in all participants	The investigators collected the result of complete blood cell count (CBC) of all participants. Then the investigators would compare CBC results among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Renal function test would be performed in all participants	The investigators collected the result of creatinine (the unit is micromole per liter) of all participants. Then the investigators would compare creatinine level among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Alanine aminotransferase would be measured in all participants	The results of measurement of alanine aminotransferase (ALT) (the unit is unit per liter) would be collected. Then the investigators would compare ALT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Aspartate aminotransferase would be measured in all participants	The results of measurement of aspartate aminotransferase (AST) (the unit is unit per liter) would be collected. Then the investigators would compare AST among the participants having different driver mutation. Meanwhile, these would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Alkaline phosphatase would be measured in all participants	The results of measurement of alkaline phosphatase (ALP) (the unit is unit per liter) would be collected. Then the investigators would compare ALP among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Gamma-glutamyl transferase would be measured in all participants	The results of measurement of gamma-glutamyl transferase (GGT) (the unit is unit per liter) would be collected. Then the investigators would compare GGT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood electrolyte level would be tested	The investigators collected the result of sodium, potassium, calcium, chloride, phosphate and magnesium (the unit is millimole per liter) of all participants. Then the investigators would compare these among the participants having different driver mutation. Meanwhile, these would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of total glycerol would be performed	The investigators collected the result of total glycerol (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of total cholesterol would be performed	The investigators collected the result of total cholesterol (the unit is micromole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of low density lipoprotein cholesterol (LDL-C) would be performed	The investigators collected the result of LDL-C (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Measurement of high density lipoprotein cholesterol (HDL-C) would be performed	The investigators collected the result of HDL-C (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.
Fasting blood glucose (FBG) test would be performed	The investigators collected the result of FBG (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.	The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359.
• Al-Samkari H, Leiva O, Dagogo-Jack I, Shaw A, Lennerz J, Iafrate AJ, Bendapudi PK, Connors JM. Impact of ALK Rearrangement on Venous and Arterial Thrombotic Risk in NSCLC. J Thorac Oncol. 2020 Sep;15(9):1497-1506. doi: 10.1016/j.jtho.2020.04.033. Epub 2020 May 11.
• Roopkumar J, Poudel SK, Gervaso L, Reddy CA, Velcheti V, Pennell NA, McCrae KR, Khorana AA. Risk of thromboembolism in patients with ALK- and EGFR-mutant lung cancer: A cohort study. J Thromb Haemost. 2021 Mar;19(3):822-829. doi: 10.1111/jth.15215. Epub 2021 Jan 24. Erratum In: J Thromb Haemost. 2021 Nov;19(11):2902.
• Zhu VW, Zhao JJ, Gao Y, Syn NL, Zhang SS, Ou SI, Bauer KA, Nagasaka M. Thromboembolism in ALK+ and ROS1+ NSCLC patients: A systematic review and meta-analysis. Lung Cancer. 2021 Jul;157:147-155. doi: 10.1016/j.lungcan.2021.05.019. Epub 2021 May 20.
• Qian X, Fu M, Zheng J, Zhou J, Zhou J. Driver Genes Associated With the Incidence of Venous Thromboembolism in Patients With Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 29;11:680191. doi: 10.3389/fonc.2021.680191. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cross-sectional Study; Clinical Characteristics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022LY0414

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