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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04228237
Other study ID # CPFS/Reg18.01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2025

Study information

Verified date March 2022
Source Ceska Lekarska Spolecnost Jana Evangelisty Purkyne z.s.
Contact Jana Alahakoon
Phone +420602350988
Email jana.alahakoon@oaks.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2300
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - clinical diagnosis of lung cancer (C34 in MKN classification) Exclusion Criteria:

Study Design


Locations

Country Name City State
Czechia University hospital Brno Brno
Czechia University hospital Hradec Kralove Hradec Kralove
Czechia University hospital Olomouc Olomouc
Czechia University hospital Plzen Plzen
Czechia University Thomayer hospital Prague
Czechia University hospital Motol Praha 5
Czechia University hospital Bulovka Praha 8 Ceská Republika

Sponsors (2)

Lead Sponsor Collaborator
Ceska Lekarska Spolecnost Jana Evangelisty Purkyne z.s. OAKS Consulting s.r.o.

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) Time from randomization until death from any cause 60 months of follow-up
Primary Progression-free survival (PFS) Time from randomization until disease progression or death any treatment during 60 months of follow-up
Primary Time to treatment discontinuation (TTD) time from starting a medication until treatment discontinuation or death any treatment during 60 months of follow-up
Secondary Time to next treatment (TTNT) Time from end of primary treatment to institution of next therapy 60 months of follow-up
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