Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

Lung Cancer Clinical Trial

— KBP-2020-CPHG  

Official title:

Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402099
• Other study ID #: 2019-A00943-54
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2020
• Source: Collège des Pneumologues des Hôpitaux Généraux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade.

Primary endpoint:

Estimate 1-year- and 5-year-mortality rates in patients with PLC.

Secondary endpoints:

• Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020

• Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies

• Estimate prognostic factors

• Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and KBP-2000-CPHG studies

• Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG studies

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020*

• Follow-up by a lung specialist at a General Hospital

• Oral informed consent * date of collected sample

Exclusion Criteria:

• Age < 18 years

• Secondary lung cancer

• Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery

• Previous enrolment in the study

• Freedom deprived patient following a legal or administrative decision

• Patient unable to give his(her) consent

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Collège des Pneumologues des Hôpitaux Généraux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate 1-year mortality rates in patients with PLC.	Global survival at 1 year	1 year
Primary	Estimate 5-year mortality rates in patients with PLC.	Global survival at 5 years	5 years
Secondary	Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020	- Patient data: age, gender, birth location, height, weight, comorbidity score, smoking status, cannabis uptake, Performance Status, and death	1 year
Secondary	Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies	- Disease data: diagnostic method, anatomopathological classification, PDL-1 status, molecular biology test, tumor mutation burden, TNM classification, and stage (8th edition)	1 year