NCT04228237

Brief Summary

Long-term non-interventional monitoring of diagnostics and treatment patterns in newly diagnosed patients in selected pneumology centers in Czech republic.

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
2,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

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

Study Start

First participant enrolled

June 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

7 years

First QC Date

October 31, 2019

Last Update Submit

March 7, 2022

Conditions

Keywords

lung cancerbronchogenic carcinomadiagnosistreatmentnon-interventional

Outcome Measures

Primary Outcomes (3)

  • Overall survival (OS)

    Time from randomization until death from any cause

    60 months of follow-up

  • Progression-free survival (PFS)

    Time from randomization until disease progression or death

    any treatment during 60 months of follow-up

  • Time to treatment discontinuation (TTD)

    time from starting a medication until treatment discontinuation or death

    any treatment during 60 months of follow-up

Secondary Outcomes (1)

  • Time to next treatment (TTNT)

    60 months of follow-up

Eligibility Criteria

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

all newly diagnosed patients in participating pulmonology centers

You may qualify if:

  • \- clinical diagnosis of lung cancer (C34 in MKN classification)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University hospital Brno

Brno, 62500, Czechia

RECRUITING

University hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

University hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

University hospital Plzen

Pilsen, 30599, Czechia

RECRUITING

University Thomayer hospital

Prague, 140 59, Czechia

RECRUITING

University hospital Motol

Prague, 15006, Czechia

RECRUITING

University hospital Bulovka

Prague, Česká Republika, 18000, Czechia

RECRUITING

Related Publications (1)

  • Venclicek O, Skrickova J, Brat K, Fischer O, Havel L, Hrnciarik M, Marel M, Opalka P, Krakorova G, Rozsivalova D, Kultan J, Mullerova A, Zarnayova L, Smickova P, Vasakova M, Gyorfy Z, Jirousek M, Krejci D, Krejci J, Zuna P, Svaton M, Hrda K, Duba J, Alahakoon J, Svoboda M, Silar J. Lung Cancer in Non-smokers in Czech Republic: Data from LUCAS Lung Cancer Clinical Registry. Anticancer Res. 2021 Nov;41(11):5549-5556. doi: 10.21873/anticanres.15368.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, BronchogenicDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBronchial NeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martina Koziar Vasakova, Prof.

    University Thomayer hospital Prague

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 31, 2019

First Posted

January 14, 2020

Study Start

June 1, 2018

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations