LUng CAncer focuS - Long-term Monitoring of Bronchogenic Carcinoma Patients (LUCAS) (LUCAS)

March 7, 2022 updated by: Ceska Lekarska Spolecnost Jana Evangelisty Purkyne z.s.

LUng CAncer focuS - Long Term Non-interventional Monitoring of Diagnostic and Treatment Patterns in Patients With Bronchogenic Carcinoma (LUCAS)

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

Diagnosis, treatment and care of patients with bronchogenic carcinoma (BCA) is, as with most other oncological diseases, a complex multidisciplinary process. Due to the lack of information on the speed and success of the initial diagnosis, the use of the necessary laboratory techniques, and the individual therapeutic steps leading to cure or medical failure, the Czech Pneumological and Phtizeology Society (CPPS) decided to carry out long-term non-interventional monitoring of newly diagnosed patients.

This monitoring is non-interventional, so the usual diagnostic and therapeutic procedures will be used according to the decision of the physician. All patients with bronchogenic carcinoma diagnosed from June 1, 2018 will be enrolled with up to 60 months of follow-up.

Study Type

Observational

Enrollment (Anticipated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • University Hospital Brno
        • Contact:
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • University hospital Hradec Králové
        • Contact:
      • Olomouc, Czechia, 77900
        • Recruiting
        • University Hospital Olomouc
        • Contact:
      • Plzen, Czechia, 30599
        • Recruiting
        • University Hospital Plzen
        • Contact:
      • Prague, Czechia, 140 59
        • Recruiting
        • University Thomayer Hospital
        • Contact:
      • Praha 5, Czechia, 15006
        • Recruiting
        • University Hospital Motol
        • Contact:
    • Česká Republika
      • Praha 8, Česká Republika, Czechia, 18000
        • Recruiting
        • University Hospital Bulovka
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all newly diagnosed patients in participating pulmonology centers

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 60 months of follow-up
Time from randomization until death from any cause
60 months of follow-up
Progression-free survival (PFS)
Time Frame: any treatment during 60 months of follow-up
Time from randomization until disease progression or death
any treatment during 60 months of follow-up
Time to treatment discontinuation (TTD)
Time Frame: any treatment during 60 months of follow-up
time from starting a medication until treatment discontinuation or death
any treatment during 60 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to next treatment (TTNT)
Time Frame: 60 months of follow-up
Time from end of primary treatment to institution of next therapy
60 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceska Lekarska Spolecnost Jana Evangelisty Purkyne z.s.

Collaborators

OAKS Consulting s.r.o.

Investigators

  • Principal Investigator: Martina Koziar Vasakova, Prof., University Thomayer hospital Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

May 31, 2025

Study Completion (ANTICIPATED)

May 31, 2025

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

January 10, 2020

First Posted (ACTUAL)

January 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPFS/Reg18.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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