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Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334864
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:

Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes.

Study type: Observational (Patient Registry)

Study design: Observational Model: Cohort

Time Perspective: Prospective and retrospective


Condition or disease
Advanced Non-small Cell Lung Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort
I Retrospective cohort
Diagnosis of advanced non-small cell lung cancer from 2012-2016
II Prospective cohort
Advanced non-small cell lung cancer with driver gene mutations
III Prospective cohort
Non-small cell lung cancer in immuno-therapy;
IV Prospective cohort
Non-small cell lung cancer with wild-type driver gene or unknown driver gene status;
V Prospective cohort
Advanced non-small lung cancer with wild-type gene treated with anti-Vascular Endothelial Growth Factor (VEGF) drug.



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 3 years ]
    OS was calculated from the diagnosis of advanced non-small cell lung cancer to death from any reasons



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
5000 advanced NSCLC patients
Criteria

Inclusion Criteria:

  • Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016;
  • Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer;
  • Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy;
  • Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status;
  • Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit;
  • Age>18 years;
  • Provision of written informed consent.

Exclusion Criteria:

  • not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334864


Contacts
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Contact: Yan Xu, M.D. 861069155039 maraxu@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yan Xu, Dr.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03334864    
Other Study ID Numbers: JS-1410
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
Advanced non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms