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Lung CancerNCT05423236

Clinical Characteristics of Lung Cancer in China

An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer
How many people
119,785 participants
Where
1 siteChina
Study dates
1 Jul 2022to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Yayi He, PhD, MD contact

+86 021-65115006

doctorjael@qq.com

China1 site
  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Yayi He, PhD, MD, +86 021-65115006, doctorjael@qq.com

    Yayi He, PhD, MD

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Lung Cancer
Keywords
Cross-sectional Study, Clinical Characteristics
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 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.

  9. 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.

    Measured: 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.

  10. 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.

    Measured: 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.

  11. 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.

    Measured: 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.

  12. 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.

    Measured: 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.

  13. 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.

    Measured: 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 outcomes (6)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
119,785 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05423236
Sponsor's protocol ID
2022LY0414
Status last verified
Jun 2022
First submitted
12 May 2022
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33433946
  • 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.

    PubMed 32437899
  • 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.

    PubMed 33314597
  • 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.

    PubMed 34049720
  • 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.

    PubMed 33996610
  • Xu K, Wang H, Li S, Zhao L, Liu X, Liu Y, Ye L, Liu X, Li L, He Y. Changing profile of lung cancer clinical characteristics in China: Over 8-year population-based study. Chin Med J Pulm Crit Care Med. 2023 Sep 15;1(3):188-194. doi: 10.1016/j.pccm.2023.08.006. eCollection 2023 Sep.

    PubMed 39171125

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yayi He, PhD, MD (+86 021-65115006, doctorjael@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive analysis of clinical characteristics of lung cancer of all participants (time frame: 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.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05423236, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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