Clinical Characteristics of Lung Cancer in China

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05423236
• Other study ID #: 2022LY0414
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, PhD, MD
• Phone: +86 021-65115006
• Email: doctorjael[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 119785
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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 202 — View Citation

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.2021.6801 — View Citation

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 2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.