NCT06255197

Brief Summary

This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe characteristics and treatment patterns and their evolving trends; (2) discover features associated with overall survival; and (3) address recently-emerging clinical questions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Nov 2019Dec 2031

Study Start

First participant enrolled

November 4, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

February 16, 2024

Status Verified

January 1, 2024

Enrollment Period

9.2 years

First QC Date

February 4, 2024

Last Update Submit

February 14, 2024

Conditions

Keywords

Lung cancerSurgeryReal world

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from surgery to death from any cause.

    January 2014 to December 2031

Secondary Outcomes (4)

  • Baseline characteristics of included participants

    January 2014 to December 2028

  • Treatment patterns of included participants

    January 2014 to December 2028

  • Pathological characteristics of included participants

    January 2014 to December 2028

  • Features associated with overall survival

    First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.

Study Arms (1)

Patients with surgically resected lung cancer

Patients who were diagnosed with lung cancer and received surgical resection in participating medical centers during the designed study period.

Eligibility Criteria

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

Participants eligible for this study would be screened from consecutive patients who received surgical resection for lung malignancies in participating medical centers during the designed study period.

You may qualify if:

  • Age above 18.
  • Have received surgical resection for lung malignancies.

You may not qualify if:

  • Participants whose data are of low quality, poor completeness or poor internal linkage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of LungCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Jie He, MD-PhD

    National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS and PUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengwei Tan, MD-PhD

CONTACT

Renda Li, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 13, 2024

Study Start

November 4, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2031

Last Updated

February 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations