NCT03334864

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
5 years until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

October 31, 2017

Last Update Submit

September 8, 2023

Conditions

Keywords

Advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS was calculated from the diagnosis of advanced non-small cell lung cancer to death from any reasons

    3 years

Study Arms (5)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

5000 advanced NSCLC patients

You may qualify if:

  • 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.

You may not qualify if:

  • not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Xu Y, Zhang L, Fang J, Wang Z, Li J, Li L, Ai B, Nie L, Mu X, Liang L, Zhang S, Zhang Y, Song Y, Song X, Wang Y, Xin T, Jin B, Wang X, Ding C, Wang M. Establishment of a prospective multicenter cohort for advanced non-small cell lung cancer in China (CAPTRA-Lung study). Thorac Cancer. 2018 Dec;9(12):1795-1800. doi: 10.1111/1759-7714.12865. Epub 2018 Sep 27.

Central Study Contacts

Yan Xu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 7, 2017

Study Start

November 3, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 11, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations